Validation of analgesic effect of nitrous oxide in neonates and infants
| ISRCTN | ISRCTN71821503 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71821503 |
| Secondary identifying numbers | N0060055834 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 18/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Neonatal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Prof Mervyn Maze
Scientific
Scientific
Magill Dept of Anaesthesia, 3rd floor
Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom
| Phone | +44 (0)181 746 8035/8816 |
|---|---|
| m.maze@imperial.ac.uk |
Study information
| Study design | Randomised controlled 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 contact details to request a participant information sheet |
| Scientific title | Validation of analgesic effect of nitrous oxide in neonates and infants |
| Study hypothesis | The purpose of this research is to validate the analgesic effect of nitrous oxide (N20) in neonates and infants. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Neonatal and infant analgesia |
| Intervention | Prospectively randomised, placebo-controlled, clinical trial. Patients randomised to: 1. Nitrous oxide 2. Placebo |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nitrous oxide |
| Primary outcome measure | 1. Neonatal pain assessment tool (developed by Keeble and Twaddle [1995]) 2. Physiologic parameters: 2.1. Blood pressure 2.2. Heart rate 2.3. Respiratory rate 2.4. Oxygen saturation |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/2000 |
| Overall study end date | 31/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 270 |
| Participant inclusion criteria | 1. Pre-term newborns (32 - 37 weeks), n = 90 2. Full-term newborns (38 - 42 weeks), n = 90 3. Infants (1 - 3 months), n = 90 |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 01/05/2000 |
| Recruitment end date | 31/10/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Chelsea & Westminster Hospital
London
SW10 9NH
United Kingdom
SW10 9NH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
University/education
Chelsea and Westminster NHS Foundation Trust (UK) - NHS R&D Support Funding
No information available
Imperial College School of Medicine (ICSM) (UK) - Research Funds
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 |
Editorial Notes
18/10/2016: No publications found, verifying study status with principal investigator.
