Condition category
Neonatal Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
18/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.dh.gov.uk/Home/fs/en

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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