Melatonin for Anxiety prior to General anaesthesia In Children (MAGIC)
| ISRCTN | ISRCTN18296119 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18296119 |
| EudraCT/CTIS number | 2018-000991-13 |
| IRAS number | 228234 |
| Secondary identifying numbers | CPMS 40234, IRAS 228234 |
- Submission date
- 08/01/2019
- Registration date
- 10/01/2019
- Last edited
- 25/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English Summary
Current plain English summary as of 23/10/2020:
Background and study aims
Midazolam is an effective premedication in anxious children undergoing general anaesthesia, but it can have considerable side effects including respiratory suppression (slow and ineffective breathing), agitation, sedation, delayed recovery, sleep disturbance and nausea/vomiting. There is therefore a need for a safer medication which is as effective at reducing anxiety as midazolam. Melatonin has been found to be as effective as midazolam in the management of pre-operative anxiety in adults, although its effectiveness in children is not confirmed. A major flaw in previous trials relates to comparing a general pre-operative child group rather than selecting for specifically-anxious children; the effects of both melatonin and any comparator are therefore weakened by those children who would not have normally been selected for premedication ahead of surgery. Melatonin has an excellent side-effect profile, and may have further advantages over midazolam in that it reduces anxiety without sedation, reduces pain and improves post-discharge sleep disturbance. The aim of this study is to assess melatonin’s effectiveness in anxious children ahead of general anaesthesia comparing it against the current standard, midazolam.
Who can participate?
Children aged 3-14 years undergoing elective dental, ophthalmological or ENT surgery under general anaesthesia, and assessed by healthcare professionals as requiring premedication
What does the study involve?
Following consent both a parent/guardian and the child complete separate questionnaires about how they feel. If the child is eligible to take part in the study, and this has been agreed by the hospital research team, then they are randomly allocated by a computer to one of the two treatment options: midazolam or melatonin. About 30 minutes before the participant is due to undergo general anaesthetic they receive their pre-medication (midazolam or melatonin). The participant is accompanied by a companion nurse during their trip from the ward into the anaesthetic room. Surgery happens as per usual care. The companion nurse sits with the parent/guardian(s) and child throughout their recovery from the surgery. They monitor the child’s recovery and check with the child as to how they are feeling. At 14 days after surgery a research nurse calls the parent/guardian(s) to ask a few simple questions about how they got on after discharge from hospital. Their child is asked to complete the same questionnaire that they completed before receiving their pre-medication.
What are the possible benefits and risks of participating?
There is a possibility that melatonin might not be as effective as midazolam at reducing anxiety, although early clinical trials have suggested that the effects of both medicines on anxiety are similar. On the day, should the child feel they cannot go ahead with the operation, the operation would be re-arranged for another day, and the child’s anaesthetist will decide which pre-medication to give them at that time as part of standard of care as they will no longer be in the study. Midazolam is known to have some serious side effects. These are the most common ones (between 1/100 and 1/10 people): sedation, sleepiness, lower levels of consciousness, respiratory depression, nausea and vomiting. Midazolam is a commonly used drug for children undergoing general anaesthesia. It is likely an anxious child would still receive this even if they don’t take part in the trial to reduce their anxiety. Melatonin is considered a very safe medicine and has no known serious side effects at the dose that will be used in this study; this is the main reason why this study is testing whether it can replace Midazolam as a pre-medication. However, all drugs have the potential to have side effects and so we could find a side effect that hasn’t been seen before. If melatonin does not sufficiently reduce the participant’s anxiety they may not be able to have their surgery on the day. This means it may need to be rearranged if not successful and the child’s anaesthetist will decide which pre-medication to give them at that time as part of standard of care as they will no longer be in the study. If the participant receives melatonin and it is successful in reducing anxiety, then it is possible that the participant will have avoided some of the known side effects of midazolam – these include breathing problems, taking longer to recovery from the anaesthetic and occasionally becoming overexcited rather than calmed. The participants will also be contributing to research that will help children who need similar medication in the future.
Where is the study run from?
University of Sheffield (UK)
When is the study starting and how long is it expected to run for?
March 2018 to December 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Marie Hyslop, m.c.hyslop@sheffield.ac.uk
_____
Previous plain English summary as of 05/08/2020:
Background and study aims
Midazolam is an effective premedication in anxious children undergoing general anaesthesia, but it can have considerable side effects including respiratory suppression (slow and ineffective breathing), agitation, sedation, delayed recovery, sleep disturbance and nausea/vomiting. There is therefore a need for a safer medication which is as effective at reducing anxiety as midazolam. Melatonin has been found to be as effective as midazolam in the management of pre-operative anxiety in adults, although its effectiveness in children is not confirmed. A major flaw in previous trials relates to comparing a general pre-operative child group rather than selecting for specifically-anxious children; the effects of both melatonin and any comparator are therefore weakened by those children who would not have normally been selected for premedication ahead of surgery. Melatonin has an excellent side-effect profile, and may have further advantages over midazolam in that it reduces anxiety without sedation, reduces pain and improves post-discharge sleep disturbance. The aim of this study is to assess melatonin’s effectiveness in anxious children ahead of general anaesthesia comparing it against the current standard, midazolam.
Who can participate?
Children aged 5-14 years undergoing elective dental, ophthalmological or ENT surgery under general anaesthesia, and assessed by healthcare professionals as requiring premedication
What does the study involve?
Following consent both a parent/guardian and the child complete separate questionnaires about how they feel. If the child is eligible to take part in the study, and this has been agreed by the hospital research team, then they are randomly allocated by a computer to one of the two treatment options: midazolam or melatonin. About 30 minutes before the participant is due to undergo general anaesthetic they receive their pre-medication (midazolam or melatonin). The participant is accompanied by a companion nurse during their trip from the ward into the anaesthetic room. Surgery happens as per usual care. The companion nurse sits with the parent/guardian(s) and child throughout their recovery from the surgery. They monitor the child’s recovery and check with the child as to how they are feeling. At 14 days after surgery a research nurse calls the parent/guardian(s) to ask a few simple questions about how they got on after discharge from hospital. Their child is asked to complete the same questionnaire that they completed before receiving their pre-medication.
What are the possible benefits and risks of participating?
There is a possibility that melatonin might not be as effective as midazolam at reducing anxiety, although early clinical trials have suggested that the effects of both medicines on anxiety are similar. On the day, should the child feel they cannot go ahead with the operation, the operation would be re-arranged for another day, and the child’s anaesthetist will decide which pre-medication to give them at that time as part of standard of care as they will no longer be in the study. Midazolam is known to have some serious side effects. These are the most common ones (between 1/100 and 1/10 people): sedation, sleepiness, lower levels of consciousness, respiratory depression, nausea and vomiting. Midazolam is a commonly used drug for children undergoing general anaesthesia. It is likely an anxious child would still receive this even if they don’t take part in the trial to reduce their anxiety. Melatonin is considered a very safe medicine and has no known serious side effects at the dose that will be used in this study; this is the main reason why this study is testing whether it can replace Midazolam as a pre-medication. However, all drugs have the potential to have side effects and so we could find a side effect that hasn’t been seen before. If melatonin does not sufficiently reduce the participant’s anxiety they may not be able to have their surgery on the day. This means it may need to be rearranged if not successful and the child’s anaesthetist will decide which pre-medication to give them at that time as part of standard of care as they will no longer be in the study. If the participant receives melatonin and it is successful in reducing anxiety, then it is possible that the participant will have avoided some of the known side effects of midazolam – these include breathing problems, taking longer to recovery from the anaesthetic and occasionally becoming overexcited rather than calmed. The participants will also be contributing to research that will help children who need similar medication in the future.
Where is the study run from?
1. Sheffield Childrens Hospital
2. Royal Aberdeen Children’s Hospital
3. Royal Bolton Hospital
4. Barnsley Hospital
5. Royal Stoke University Hospital, Stoke-on-Trent
6. Doncaster Royal Infirmary
7. Lister Hospital, Stevenage
8. Tayside Childrens Hospital
9. Royal Hospital for Children, Glasgow
10. University Hospital Crosshouse, Kilmarnock
11. Alder Hey Children's Hospital
12. Royal Manchester Children's Hospital
13. The James Cook University Hospital
14. Royal Victoria Infirmary
15. Newcastle Dental Hospital
16. Sunderland Royal Hospital
When is the study starting and how long is it expected to run for?
March 2018 to July 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Marie Hyslop, m.c.hyslop@sheffield.ac.uk
_____
Previous plain English summary:
Background and study aims
Midazolam is an effective premedication in anxious children undergoing general anaesthesia, but it can have considerable side effects including respiratory suppression (slow and ineffective breathing), agitation, sedation, delayed recovery, sleep disturbance and nausea/vomiting. There is therefore a need for a safer medication which is as effective at reducing anxiety as midazolam. Melatonin has been found to be as effective as midazolam in the management of pre-operative anxiety in adults, although its effectiveness in children is not confirmed. A major flaw in previous trials relates to comparing a general pre-operative child group rather than selecting for specifically-anxious children; the effects of both melatonin and any comparator are therefore weakened by those children who would not have normally been selected for premedication ahead of surgery. Melatonin has an excellent side-effect profile, and may have further advantages over midazolam in that it reduces anxiety without sedation, reduces pain and improves post-discharge sleep disturbance. The aim of this study is to assess melatonin’s effectiveness in anxious children ahead of general anaesthesia comparing it against the current standard, midazolam.
Who can participate?
Children aged 5-14 years undergoing elective dental, ophthalmological or ENT surgery under general anaesthesia, and assessed by healthcare professionals as requiring premedication
What does the study involve?
Following consent both a parent/guardian and the child complete separate questionnaires about how they feel. If the child is eligible to take part in the study, and this has been agreed by the hospital research team, then they are randomly allocated by a computer to one of the two treatment options: midazolam or melatonin. About 30 minutes before the participant is due to undergo general anaesthetic they receive their pre-medication (midazolam or melatonin). The participant is accompanied by a companion nurse during their trip from the ward into the anaesthetic room. Surgery happens as per usual care. The companion nurse sits with the parent/guardian(s) and child throughout their recovery from the surgery. They monitor the child’s recovery and check with the child as to how they are feeling. At 14 days after surgery a research nurse calls the parent/guardian(s) to ask a few simple questions about how they got on after discharge from hospital. Their child is asked to complete the same questionnaire that they completed before receiving their pre-medication.
What are the possible benefits and risks of participating?
There is a possibility that melatonin might not be as effective as midazolam at reducing anxiety, although early clinical trials have suggested that the effects of both medicines on anxiety are similar. On the day, should the child feel they cannot go ahead with the operation, the operation would be re-arranged for another day, and the child’s anaesthetist will decide which pre-medication to give them at that time as part of standard of care as they will no longer be in the study. Midazolam is known to have some serious side effects. These are the most common ones (between 1/100 and 1/10 people): sedation, sleepiness, lower levels of consciousness, respiratory depression, nausea and vomiting. Midazolam is a commonly used drug for children undergoing general anaesthesia. It is likely an anxious child would still receive this even if they don’t take part in the trial to reduce their anxiety. Melatonin is considered a very safe medicine and has no known serious side effects at the dose that will be used in this study; this is the main reason why this study is testing whether it can replace Midazolam as a pre-medication. However, all drugs have the potential to have side effects and so we could find a side effect that hasn’t been seen before. If melatonin does not sufficiently reduce the participant’s anxiety they may not be able to have their surgery on the day. This means it may need to be rearranged if not successful and the child’s anaesthetist will decide which pre-medication to give them at that time as part of standard of care as they will no longer be in the study. If the participant receives melatonin and it is successful in reducing anxiety, then it is possible that the participant will have avoided some of the known side effects of midazolam – these include breathing problems, taking longer to recovery from the anaesthetic and occasionally becoming overexcited rather than calmed. The participants will also be contributing to research that will help children who need similar medication in the future.
Where is the study run from?
1. Sheffield Childrens Hospital
2. Royal Aberdeen Children’s Hospital
3. Royal Bolton Hospital
4. Addenbrookes Hospital
5. Croydon University Hospital
6. Doncaster Royal Infirmary
7. Darlington Memorial Hospital
8. Tayside Childrens Hospital
9. Royal Hospital for Children, Glasgow
10. University Hospital Crosshouse
11. Alder Hey Children's Hospital
12. Royal Manchester Children's Hospital
13. Medway Maritime Hospital, Medway
14. The James Cook University Hospital
15. Royal Victoria Infirmary
16. Newcastle Dental Hospital
17. Sunderland Royal Hospital
When is the study starting and how long is it expected to run for?
March 2018 to July 2021
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Dr Anna Thomason
a.l.thomason@sheffield.ac.uk
Contact information
Scientific
Clinical Trials Research Unit
ScHARR
University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
| Phone | +44 (0)114 222 4347 |
|---|---|
| m.c.hyslop@sheffield.ac.uk |
Study information
| Study design | Randomized; Both; Design type: Process of Care, Drug, Qualitative |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The MAGIC trial (Melatonin for Anxiety prior to General anaesthesia In Children): A Multicentre, Parallel Randomised Controlled Trial of Melatonin Versus Midazolam in the Premedication of Anxious Children Attending for Elective Dental, Ophthalmologic or ENT Surgery Under General Anaesthesia |
| Study acronym | MAGIC |
| Study hypothesis | Melatonin is not inferior to midazolam in reducing anxiety in children pre-GA with fewer side effects. |
| Ethics approval(s) | Approved 16/01/2019, North West – Liverpool Central Research Ethics Committee (3rd Floor Barlow House, 4 Minshull Street, Manchester, M1 3DZ; +44 (0)207 104 8196; nrescommittee.northwest-liverpoolcentral@nhs.net), ref: 18/NW/0758 |
| Condition | Anxiety prior to general anaesthesia |
| Intervention | Current interventions as of 23/10/2020: This study: 1. Has two arms: melatonin vs midazolam 2. Is a parallel design i.e. patients will be allocated at a 1:1 ratio between the two arms 3. Is double blinded whereby the anaesthetists, surgeons and observer nurses will be fully blinded, with patient allocation concealment. Pharmacists will be unblinded 4. Will recruit both parents and children for participation in the trial. Parents will be asked to complete questionnaires on their anxiety as part of their participation 5. Is multicentre The study is comprised of the feasibility pilot (first 6 months of recruitment) and the main study (the remaining recruitment period). There will be a stop/go decision at the end of the pilot phase based on recruitment and retention of during the first 6 months. A traffic light system defines the levels of recruitment and retention required in order for the main trial to continue. Qualitative interviews with parents, children and research staff shall also inform the trialists on the success of enrolment during the internal pilot, identify any problems encountered and assist recruitment during the main trial. Further qualitative interviews in the main trial shall provide insight into stakeholder and patient acceptability of melatonin. Eligible patients will have the following assessments, typically all on the same day: 1. Consent: Candidates (children and their parents) candidates shall be approached for consent by a suitably qualified medical professional (including research nurses). 2. Randomisation 3. Baseline: On the morning of surgery, following consent and randomisation , the following assessments will be completed: 3.1. American Society of Anaestheiologists (ASA) physical status 3.2. State-Trait Anxiety Inventory (STAI) 3.3. Modified Yale Preoperative Anxiety Scale (mYPAS) 3.4. Child Health Utility 9D questionnaire (CHU9D) 3.5. Cooperation score and resource use 4. Drug administration: Drug will be administered 30 minutes prior to the patient transfer by a member of the team who has been delegated to do so 5. Transfer to Theatre Admissions Unit (TAU): Following administration, a second, blinded, assessor will accompany the patient on transfer to the TAU. The following information will be collected following transfer and prior to surgery: 5.1. mYPAS 5.2. Additional medication given 5.3. Adverse events 6. Surgery: During surgery the following information should be recorded: 6.1. Completion of surgery 6.2. Time of extubation 6.3. Additional medication given 6.4. Adverse events 7. Post-surgery: Post-surgery the following information should be recorded: 7.1. Additional medication given including analgesia usage 7.2. Adverse events 7.3. Time to Post Anaesthesia Care Unit (PACU) 7.4. Vital signs 7.5. Time to discharge readiness 7.6. Time to actual discharge 8. In Post Anesthesia Care Unit (PACU): 8.1. Patient reported Faces Pain Score – Revised (FPS-R) every 15 minutes in PACU until discharge/maximum 2 hours whichever is first 8.2. Observer reported FPS-R every 15 minutes in PACU until discharge/maximum 2 hours whichever is first 8.3. Cooperation score every 15 minutes in PACU until discharge/maximum 2 hours whichever is first 8.4. Paediatric anaesthesia emergence delirium (PAED) index every 15 minutes in PACU until discharge/maximum 2 hours whichever is first 8.5. Vancouver Sedation Recovery Scale (VSR) every 15 minutes in PACU until discharge/maximum 2 hours whichever is first 9. 14 day follow up via phone: The following assessments should be completed: 9.1. Adverse events 9.2. PHBQ 9.3. CHU9D The trialists are proposing to undertake a sub-study, using a Study With a Trial (SWAT) design to evaluate the effectiveness of a personalised text message including the recipient’s name, versus a standard text message for prompting response in trial participants to answer and complete telephone follow-up questionnaires in MAGIC. Participants of the MAGIC trial who provide a mobile phone number will be randomly allocated to receive either a personalised or standard text message prior to their follow-up telephone call. This SWAT should not represent any further burden to participants. Data from the SWAT will contribute to the ‘PROmoting THE Use of SWATs’ (PROMETHEUS) Programme (hosted by York Trials Unit at the University of York and supported by funding from MRC (https://www.york.ac.uk/healthsciences/research/trials/research/swats/prometheus/) and will help to increase the evidence base on the recruitment of participants to trials. _____ Previous interventions: This study: 1. Has two arms: melatonin vs midazolam 2. Is a parallel design i.e. patients will be allocated at a 1:1 ratio between the two arms 3. Is double blinded whereby the anaesthetists, surgeons and observer nurses will be fully blinded, with patient allocation concealment. Pharmacists will be unblinded 4. Will recruit both parents and children for participation in the trial. Parents will be asked to complete questionnaires on their anxiety as part of their participation 5. Is multicentre The study is comprised of the feasibility pilot (first 6 months of recruitment) and the main study (the remaining recruitment period). There will be a stop/go decision at the end of the pilot phase based on recruitment and retention of during the first 6 months. A traffic light system defines the levels of recruitment and retention required in order for the main trial to continue. Qualitative interviews with parents, children and research staff shall also inform the trialists on the success of enrolment during the internal pilot, identify any problems encountered and assist recruitment during the main trial. Further qualitative interviews in the main trial shall provide insight into stakeholder and patient acceptability of melatonin. Eligible patients will have the following assessments, typically all on the same day: 1. Consent: Candidates (children and their parents) candidates shall be approached for consent by a suitably qualified medical professional (including research nurses). 2. Randomisation 3. Baseline: On the morning of surgery, following consent and randomisation , the following assessments will be completed: 3.1. American Society of Anaestheiologists (ASA) physical status 3.2. State-Trait Anxiety Inventory (STAI) 3.3. Modified Yale Preoperative Anxiety Scale (mYPAS) 3.4. Child Health Utility 9D questionnaire (CHU9D) 3.5. Cooperation score and modified post-box test 4. Drug administration: Drug will be administered 30 minutes prior to the patient transfer by a member of the team who has been delegated to do so 5. Transfer to Theatre Admissions Unit (TAU): Following administration, a second, blinded, assessor will accompany the patient on transfer to the TAU. The following information will be collected following transfer and prior to surgery: 5.1. mYPAS 5.2. Additional medication given 5.3. Adverse events 6. Surgery: During surgery the following information should be recorded: 6.1. Completion of surgery 6.2. Time of extubation 6.3. Additional medication given 6.4. Adverse events 7. Post-surgery: Post-surgery the following information should be recorded: 7.1. Additional medication given including analgesia usage 7.2. Adverse events 7.3. Time to Post Anaesthesia Care Unit (PACU) 7.4. Vital signs 7.5. Time to discharge readiness 7.6. Time to actual discharge 8. In Post Anesthesia Care Unit (PACU): 8.1. Patient reported Faces Pain Score – Revised (FPS-R) every 10 minutes in PACU until stage 2 anaesthetic recovery is completed 8.2. Observer reported FPS-R every 10 minutes in PACU until stage 2 anaesthetic recovery is completed 8.3. Cooperation score and modified post-box test 8.4. Paediatric anaesthesia emergence delirium (PAED) index every 10 minutes in PACU until stage 2 anaesthetic recovery is completed 8.5. Vancouver Sedation Recovery Scale (VSR) every 10 minutes in PACU until stage 2 anaesthetic recovery is completed 9. 14 day follow up via phone: The following assessments should be completed: 9.1. Adverse events 9.2. PHBQ 9.3. CHU9D The trialists are proposing to undertake a sub-study, using a Study With a Trial (SWAT) design to evaluate the effectiveness of a personalised text message including the recipient’s name, versus a standard text message for prompting response in trial participants to answer and complete telephone follow-up questionnaires in MAGIC. Participants of the MAGIC trial who provide a mobile phone number will be randomly allocated to receive either a personalised or standard text message prior to their follow-up telephone call. This SWAT should not represent any further burden to participants. Data from the SWAT will contribute to the ‘PROmoting THE Use of SWATs’ (PROMETHEUS) Programme (hosted by York Trials Unit at the University of York and supported by funding from MRC (https://www.york.ac.uk/healthsciences/research/trials/research/swats/prometheus/) and will help to increase the evidence base on the recruitment of participants to trials. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Melatonin, midazolam |
| Primary outcome measure | Preoperative distress measured using the modified Yale Preoperative Anxiety Scale (mYPAS); Timepoint(s): baseline, start of transfer to TAU, entry to TAU, administration of anaesthesia |
| Secondary outcome measures | Safety: 1. Mortality measured using PAED assessment post-surgery 2. Post-surgical recovery measured using VSR and FPS-R post-surgery 3. Post-discharge behaviour measured using PHBQ at 14 days follow-up 4. Analgesia requirements and adverse events measured using the concomitant medication and adverse events collected pre-, during and post-surgery 5. Orientation and cognitive/psychomotor function measured using the cooperation score post-surgery 6. Serious adverse events reported at pre- and post-surgery and 14 days Efficacy: 1. Anaesthetic turnaround time and recovery time measured using time of induction of anesthesia, time of surgery completion and time to discharge 2. Anaesthetic failure rate measured using anaesthesia abandonment cases pre-surgery Qualitative: 1. Recruitment experiences and acceptability of the two drugs assessed using responses from interviews with patients and stakeholders at interviews held post the 14 days follow-up Economic: 1. The cost-effectiveness of introducing melatonin, compared to midazolam, over the study period. A decision tree model will be developed to estimate cost-effectiveness and cost per QALY over a 1-year period |
| Overall study start date | 01/03/2018 |
| Overall study end date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 1650; UK Sample Size: 1650; (child sample size: 624) |
| Total final enrolment | 110 |
| Participant inclusion criteria | Current inclusion criteria as of 23/10/2020: 1. Children aged 3-14 years undergoing elective dental, ophthalmological or ENT surgery under general anaesthesia 2. Pragmatically assessed by healthcare professionals as requiring premedication as per local standard care for high/expected high levels of preoperative distress prior to elective dental/ENT/ophthalmological surgery under general anaesthetic, including known negative experiences, failed anaesthesia, parents displaying high levels of distress, additional/special needs or judged as unable to tolerate general anaesthetic without premedication 3. ASA grades I & II 4. Parent or person with parental responsibility able to give written, informed consent and child willing to assent _____ Previous inclusion criteria: 1. Children aged 5-14 years undergoing elective dental, ophthalmological or ENT surgery under general anaesthesia 2. Pragmatically assessed by healthcare professionals as requiring premedication as per local standard care for high/expected high levels of preoperative distress prior to elective dental/ENT/ophthalmological surgery under general anaesthetic, including known negative experiences, failed anaesthesia, parents displaying high levels of distress, additional/special needs or judged as unable to tolerate general anaesthetic without premedication 3. ASA grades I & II 4. Parent or person with parental responsibility able to give written, informed consent and child willing to assent |
| Participant exclusion criteria | Current exclusion criteria as of 23/10/2020: 1. Not undergoing elective, day-case dental, ophthalmological or ENT surgery under general anaesthesia 2. Not displaying level of anxiety that would usually warrant premedication under the standard NHS care pathway 3. Reason for premedication other than anxiety 4. Current prescription of melatonin, midazolam or other non-permitted drug (please see protocol) 5. Obstructive sleep apnoea 6. ASA grades III, IV & V 7. Severe learning disability rendering child unable to communicate even with specialised support 8. Parent declines for their child to participate in the trial _____ Previous exclusion criteria: 1. Not undergoing elective, day-case dental, ophthalmological or ENT surgery under general anaesthesia 2. Not displaying level of anxiety that would usually warrant premedication under the standard NHS care pathway 3. Reason for premedication other than anxiety 4. Current prescription of melatonin, midazolam or other non-permitted drug (please see section 7.11.2) 5. Obstructive sleep apnoea 6. ASA grades III, IV & V 7. Severe learning disability rendering child unable to communicate even with specialised support |
| Recruitment start date | 10/07/2019 |
| Recruitment end date | 13/03/2023 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Clarkson St
Sheffield
S10 2TQ
United Kingdom
Aberdeen
AB25 2ZG
United Kingdom
Farnworth
Bolton
BL4 0JR
United Kingdom
Doncaster
DN2 5LT
United Kingdom
DD1 9SY
United Kingdom
Glasgow
G51 4TF
United Kingdom
Crosshouse
Kilmarnock
KA2 0BE
United Kingdom
Liverpool
L14 5AB
United Kingdom
Manchester
M13 9WL
United Kingdom
Middlesbrough
TS4 3BW
United Kingdom
Newcastle upon Tyne
NE1 4LP
United Kingdom
Newcastle upon Tyne
NE2 4AZ
United Kingdom
Sunderland
SR4 7TP
United Kingdom
Hertfordshire
Stevenage
SG1 4AB
United Kingdom
Barnsley
S75 2EP
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Alessia Dunn
Northern General Hospital
Herries Road
Sheffield
S5 7AU
England
United Kingdom
| Phone | +44 (0)114 271 2550 |
|---|---|
| alessia.dunn@sth.nhs.uk | |
"ROR" |
https://ror.org/018hjpz25 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 31/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Current publication and dissemination plan as of 16/02/2024: Planned publication in high impact journal (BJA). Results were also disseminated to all patients and their parents who participated. This was done by trial summary leaflets (age-specific) sent directly via post. Previous publication and dissemination plan: The protocol will be available online via the MAGIC website once approvals have been received. The statistical analysis plan will not be made publicly available at this time. |
| IPD sharing plan | Current IPD sharing plan as of 19/02/2024: The dataset generated and analysed during the trial is available upon request. The dataset is stored at the University of Sheffield on a secure network. 1. The name and email address of the investigator/body who should be contacted for access to the datasets: Currently CI - Prof. Chris Deery (custodian) - c.deery@sheffield.ac.uk 2. The type of data that will be shared: anonymised dataset 3. Dates of availability: until 30th June 2048 (25 years after the end of the study) 4. Whether consent from participants was required and obtained: consent from particpants was obtained 5. Comments on data anonymization: all data will be anonymised Previous IPD sharing plan: The datasets generated during and/or analysed during the current study are/will be available upon request. The dataset will be stored at the University of Sheffield on a secure network. Details of the data-sharing requirements are not yet available. Various details of the dataset will be included in the publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | qualitative internal pilot study | 16/07/2021 | 19/07/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 10/11/2023 | 13/11/2023 | Yes | No | |
| Other publications | embedded randomised controlled retention trial | 07/02/2024 | 07/02/2024 | Yes | No |
| Statistical Analysis Plan | version 3 | 16/02/2024 | No | No | |
| Protocol file | version 4.1 | 28/09/2020 | 20/02/2024 | No | No |
| Results article | Acceptability qualitative interview study results | 05/12/2024 | 11/12/2024 | Yes | No |
| Other publications | Barriers and enablers to recruiting participants | 04/02/2025 | 25/02/2025 | Yes | No |
Additional files
Editorial Notes
25/02/2025: Publication reference added.
11/12/2024: Publication reference added.
20/02/2024: Protocol uploaded.
19/02/2024: IPD sharing plan added.
16/02/2024: Statistical analysis plan and IRAS number added, publication and dissemination plan and IPD sharing plan updated.
07/02/2024: Publication reference added.
13/11/2023: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
13/03/2023: The recruitment end date was changed from 31/07/2023 to 13/03/2023.
22/06/2022: The following changes have been made:
1. The recruitment end date has been changed from 15/07/2021 to 31/07/2023.
2. The overall trial end date has been changed from 15/07/2022 to 31/12/2023 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 15/07/2022 to 31/07/2024.
19/07/2021: Publication reference added.
23/10/2020: The following changes were made to the trial record:
1. The interventions were changed.
2. The trial website was changed from "https://www.sheffield.ac.uk/scharr/magic"; to "https://www.sheffield.ac.uk/scharr/research/centres/ctru/magic";.
3. The inclusion criteria were changed.
4. The target number of participants were updated. "(child sample size - 624)" was added.
5. The exclusion criteria were changed.
6. Royal Stoke University Hospital was removed from the trial participating centres.
7. The plain English summary was updated to reflect these changes.
8. The recruitment resumed.
05/08/2020: The following changes were made to the trial record:
1. The overall end date was changed from 15/07/2021 to 15/07/2022.
2. The recruitment end date was changed from 15/07/2020 to 15/07/2021.
3. The trial participating centres "Addenbrookes Hospital, Croydon University Hospital, Darlington Memorial Hospital, Medway Maritime Hospital, Medway" were removed and "Lister Hospital, Royal Stoke University Hospital, Barnsley Hospital" were added.
4. The plain English summary was updated to reflect these changes.
17/04/2020: Due to current public health guidance, recruitment for this study has been paused.
24/07/2019: The following changes were made to the trial record:
1. The recruitment start date was changed from 15/03/2019 to 10/07/2019.
2. The participant inclusion criteria: Age group was changed from Adult to Child.
3. Marie Hyslop, m.c.hyslop@sheffield.ac.uk was added as a scientific contact.
4. Dr Anna Thomason, a.l.thomason@sheffield.ac.uk was removed as a scientific contact.
5. The plain English summary was updated to reflect these changes.
6. The ethics approval was added.
25/03/2019: The condition has been changed from "Specialty: Anaesthesia, Perioperative Medicine and Pain Management, Primary sub-specialty: Anaesthesia, Perioperative Medicine and Pain Management; Health Category: Mental health" to "Anxiety prior to general anaesthesia" following a request from the NIHR.
11/01/2019: Internal review.
