Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
02/11/2016
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

Dr M R J Sury

ORCID ID

Contact details

Anaesthetics
Great Ormond Street Hospital
Great Ormond Street
London
WC1N 3JH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0012128260

Study information

Scientific title

Double-blind randomised study into the efficacy of codeine phosphate analgesia after cleft palate repair in infants

Acronym

Study hypothesis

How effective is codeine phosphate after cleft palate repair in infants and how much is metabolised to morphine in this age group?

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

Cleft palate repair

Intervention

1. Codeine phosphate after cleft palate repair
2. No codeine phosphate

Intervention type

Drug

Phase

Not Applicable

Drug names

Codeine phosphate

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2003

Overall trial end date

31/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Children who have cleft palate

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/02/2003

Recruitment end date

31/08/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Great Ormond Street Hospital
London
WC1N 3JH
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

Government

Funder name

Great Ormond Street Hospital for Children NHS Trust/Institute of Child Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Association of Paediatric Anaesthetists

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

02/11/2016: No publications found, verifying study status with principal investigator.