Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
16/04/2015
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 PD Booker

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0206152406

Study information

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

Acronym

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

Not provided at time of registration

Study design

Randomised prospective blinded comparative study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Post operative pain

Intervention

S(+)ketamin or morphine by direct continuous infusion.

Intervention type

Drug

Phase

Not Applicable

Drug names

S(+)ketamin and morphine

Primary outcome measures

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 trial start date

11/10/2004

Overall trial end date

30/11/2007

Reason abandoned

Eligibility

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 type

Patient

Age group

Child

Gender

Both

Target number of participants

70

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

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Liverpool Children's Hospital NHS Trust
Liverpool
L12 2AP
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

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

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