Contact information
Type
Scientific
Primary contact
Prof Mervyn Maze
ORCID ID
Contact details
Magill Dept of Anaesthesia
3rd floor
Chelsea & Westminster Hospital
369 Fulham Road
London
SW10 9NH
United Kingdom
+44 (0)181 746 8035/8816
m.maze@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0060055834
Study information
Scientific title
Validation of analgesic effect of nitrous oxide in neonates and infants
Acronym
Study hypothesis
The purpose of this research is to validate the analgesic effect of nitrous oxide (N20) in neonates and infants.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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 names
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 trial start date
01/05/2000
Overall trial end date
31/10/2005
Reason abandoned (if study stopped)
Eligibility
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 type
Patient
Age group
Neonate
Gender
Both
Target number of participants
270
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
United Kingdom
Trial participating centre
Chelsea & Westminster Hospital
London
SW10 9NH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
University/education
Funder name
Chelsea and Westminster NHS Foundation Trust (UK) - NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Imperial College School of Medicine (ICSM) (UK) - Research Funds
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list