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
Secondary identifying numbers	N0206152406

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

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

Study design	Randomised prospective blinded comparative study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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 hypothesis	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
Condition	Post operative pain
Intervention	S(+)ketamin or morphine by direct continuous infusion.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	S(+)ketamin and morphine
Primary outcome measure	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.
Secondary outcome measures	Not provided at time of registration
Overall study start date	11/10/2004
Overall study end date	30/11/2007

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	70
Participant 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.
Participant 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
Recruitment start date	11/10/2004
Recruitment end date	30/11/2007

Royal Liverpool Children's Hospital NHS Trust

Liverpool
L12 2AP
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Government

Royal Liverpool Children's NHS Trust (UK), NHS R&D Support Funding

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan