Condition category
Signs and Symptoms
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
26/10/2015
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 AS Carr

ORCID ID

Contact details

Anaesthetic Department
Level 04
Derriford Hospital
Derriford
Plymouth
PL6 8DH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0185088382

Study information

Scientific title

A comparison of analgesic efficacy and postoperative nausea and vomiting following morphine or fentanyl for perioperative analgesia in paediatric adenotonsillectomy

Acronym

Study hypothesis

To determine whether there is a difference in vomiting episodes or analgesic requirements after use of morphine or fentanyl during adenotonsillectomy operation.

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 the contact details below to request a patient information sheet

Condition

Signs and Symptoms: Vomiting

Intervention

Children aged 5-16 years, American Society of Anesthesiologists (ASA) 1-2 scheduled for adenotonsillectomy will be recruited to the study after obtaining parental consent and verbal assent from the child, if appropriate. They will receive a standard anaesthetic. All children will receive paracetamol and diclofenac for analgesia. At induction all children will receive fentanyl. Intraoperatively they will be randomised to receive either morphine intramuscular (IM) (group M) or fentanyl (group F). Postoperatively they will receive fentanyl or morphine as rescue analgesia. Rescue antiemetic will be given if required. Postoperatively, pain and sedation scores and the number of vomiting episodes in 24 h will be assessed and the intravenous (IV) and oral morphine requirements over 24 h.

Intervention type

Drug

Phase

Not Applicable

Drug names

Morphine, fentanyl

Primary outcome measures

The following outcome measures will be used: pain scores, sedation scores, numbering of vomiting episodes in 24 h, IV and oral opioid requirements in 24 h.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

15/04/2002

Overall trial end date

15/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

15/04/2002

Recruitment end date

15/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Derriford Hospital
Plymouth
PL6 8DH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Funder name

Plymouth Hospitals NHS Trust (UK)

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

26/10/2015: no publications found on PubMed