Randomised, blinded, comparison of the respiratory depressant effects of morphine and S(+) ketamin infusions when used to provide postoperative analgesia in infants undergoing major surgery

ISRCTN	ISRCTN99206122
DOI	https://doi.org/10.1186/ISRCTN99206122
Protocol serial number	N0206152406
Sponsor	Department of Health
Funder	Royal Liverpool Children's NHS Trust (UK), NHS R&D Support Funding

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

Dr PD Booker
Scientific

Anaesthesia Department
Royal Liverpool Children's Hospital NHS Trust
Eaton Road
Liverpool
L12 2AP
United Kingdom

Primary study design	Interventional
Study design	Randomised prospective blinded comparative study
Secondary study design	Randomised controlled trial
Scientific title	Randomised, blinded, comparison of the respiratory depressant effects of morphine and S(+) ketamin infusions when used to provide postoperative analgesia in infants undergoing major surgery
Study objectives	Null hypothesis: the incidence of clinically significant respiratory depression in infants receiving equipotent analgesic doses of either S(+)ketamin or morphine by direct continuous infusion is the same.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Post operative pain
Intervention	S(+)ketamin or morphine by direct continuous infusion.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	S(+)ketamin and morphine
Primary outcome measure(s)	To use the total number of respiratory depression episodes measured over the first 24 hours after return to the ward following surgery as primary clinical relevant variable.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/11/2007

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	70
Key inclusion criteria	70 infants aged less than 60 weeks post-conceptual age undergoing elective or urgent abdominal surgery who would not be expected to require postoperative artificial ventilation.
Key exclusion criteria	1. Patients with severe CNS abnormalities 2. Patients with severe renal or hepatic dysfunction 3. Patients with post-conceptual age of <37 weeks 4. Patients requiring respiratory support preoperatively 5. Patients receiving epidural opioids or local anaesthetic drugs 6. Patients having apnoeas or periodic breathing preoperatively
Date of first enrolment	11/10/2004
Date of final enrolment	30/11/2007

Royal Liverpool Children's Hospital NHS Trust

Liverpool
L12 2AP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan