Validation of analgesic effect of nitrous oxide in neonates and infants
| ISRCTN | ISRCTN71821503 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71821503 |
| Protocol serial number | N0060055834 |
| Sponsor | Department of Health |
| Funders | Chelsea and Westminster NHS Foundation Trust (UK) - NHS R&D Support Funding, Imperial College School of Medicine (ICSM) (UK) - Research Funds |
- 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 of protocol
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Validation of analgesic effect of nitrous oxide in neonates and infants |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | Neonatal and infant analgesia |
| Intervention | Prospectively randomised, placebo-controlled, clinical trial. Patients randomised to: 1. Nitrous oxide 2. Placebo |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Nitrous oxide |
| Primary outcome measure(s) |
1. Neonatal pain assessment tool (developed by Keeble and Twaddle [1995]) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 270 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2000 |
| Date of final enrolment | 31/10/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Chelsea & Westminster Hospital
London
SW10 9NH
United Kingdom
SW10 9NH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/10/2016: No publications found, verifying study status with principal investigator.
