Does paracetamol given by mouth before wisdom tooth extraction give equal pain relief compared to paracetamol given by intravenous infusion?
| ISRCTN | ISRCTN77607163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77607163 |
| Secondary identifying numbers | RPC179 |
- Submission date
- 22/01/2008
- Registration date
- 09/05/2008
- Last edited
- 12/12/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Stephen Fenlon
Scientific
Scientific
Queen Victoria Hospital NHS Foundation Trust
Holtye Road
East Grinstead
RH19 3QE
United Kingdom
| stephen.fenlon@qvh.nhs.uk |
Study information
| Study design | Randomised, controlled, blinded trial |
|---|---|
| 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 below to request a patient information sheet |
| Scientific title | A comparison of pre-medication with oral paracetamol versus intravenous paracetamol given at time of induction for post-operative analgesia following wisdom tooth extraction |
| Study hypothesis | There is no clinically significant difference between the post-operative analgesic effects of paracetamol when given orally as a pre-medication one hour pre-operatively, and when given as an intravenous infusion immediately pre-operatively. |
| Ethics approval(s) | Brighton East Research Ethics Committee approved as of 19th February 2008 (ref: 08/H1107/16) |
| Condition | Analgesia in wisdom tooth extraction |
| Intervention | Participants will be randomly assigned to either: 1. Oral pre-med group: two 500 milligram paracetamol capsules and 100 ml bag of normal saline for injection, or 2. IV group: two placebo lactose capsules and 100 ml (1 gram) of paracetamol for injection The oral pre-medication will be given one hour prior to surgery and the intravenous whilst the participant is under a general anaesthetic. Duration of treatment 15 minutes for intravenous injection. Duration of follow up until discharged from hospital (max 3 - 4 hours). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Paracetamol |
| Primary outcome measure | We will compare the pain scores of patients in the two study arms one hour post-operatively. This will be done in recovery using a Visual Analogue Scale (VAS) pain scoring system. |
| Secondary outcome measures | We will compare the time to request of post-operative rescue analgesia between the two study arms. Specifically, this will be measured from when the patient arrives in recovery. This point will serve as a standard time zero (t0). The time elapsed before the patient requests additional analgesia (if at all) will act as a secondary surrogate marker of analgesic efficacy. |
| Overall study start date | 31/03/2008 |
| Overall study end date | 31/12/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 116 |
| Participant inclusion criteria | Patients over 18 years (either sex) having a general anaesthetic for extraction of wisdom teeth of which at least one must be a lower molar tooth. |
| Participant exclusion criteria | 1. Patients who are unable to give full consent, or who do not wish to take part in the trial 2. Patients who have a baseline Visual Analogue Scale (VAS) score of more than zero 3. Patients unable to swallow tablets 4. Patients who have taken simple analgesics that day, prior to surgery 5. Hypersensitivity or history of serious adverse reactions to paracetamol or non-steroidal anti-inflammatory drugs 6. Active liver disease 7. Renal dysfunction 8. Pregnant or breast feeding women 9. Alcohol or drug abuse 10. History of unresponsiveness to paracetamol 11. Gastric or peptic ulcer disease 12. Inflammatory bowel disease 13. Blood coagulation abnormalities |
| Recruitment start date | 31/03/2008 |
| Recruitment end date | 31/12/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Queen Victoria Hospital NHS Foundation Trust
East Grinstead
RH19 3QE
United Kingdom
RH19 3QE
United Kingdom
Sponsor information
Queen Victoria Hospital NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Holtye Road
East Grinstead
RH19 3DZ
England
United Kingdom
| sarah.dawe@qvh.nhs.uk | |
| Website | http://www.qvh.nhs.uk/ |
"ROR" |
https://ror.org/03bs2yy11 |
Funders
Funder type
Government
National Institute for Health Research (UK) - the Research for Patient Benefit (RfPB) programme
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2013 | Yes | No |
