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 of protocol

Not provided at time of registration

Contact information

Prof Mervyn Maze
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
Email m.maze@imperial.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleValidation of analgesic effect of nitrous oxide in neonates and infants
Study objectivesThe 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) studiedNeonatal and infant analgesia
InterventionProspectively randomised, placebo-controlled, clinical trial. Patients randomised to:
1. Nitrous oxide
2. Placebo
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Nitrous oxide
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/05/2000
Completion date31/10/2005

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants270
Key inclusion criteria1. 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 criteriaNot provided at time of registration
Date of first enrolment01/05/2000
Date of final enrolment31/10/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Chelsea & Westminster Hospital
London
SW10 9NH
United Kingdom

Sponsor information

Department of Health
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

18/10/2016: No publications found, verifying study status with principal investigator.