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

ISRCTN	ISRCTN62811834
DOI	https://doi.org/10.1186/ISRCTN62811834
Secondary identifying numbers	N0185088382

Submission date: 12/09/2003
Registration date: 12/09/2003
Last edited: 26/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

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

Contact information

Dr AS Carr
Scientific

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A comparison of analgesic efficacy and postoperative nausea and vomiting following morphine or fentanyl for perioperative analgesia in paediatric adenotonsillectomy
Study objectives	To determine whether there is a difference in vomiting episodes or analgesic requirements after use of morphine or fentanyl during adenotonsillectomy operation.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Morphine, fentanyl
Primary outcome measure	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 study start date	15/04/2002
Completion date	15/04/2003

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	Not provided at time of registration
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	15/04/2002
Date of final enrolment	15/04/2003

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Derriford Hospital

Plymouth
PL6 8DH
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Plymouth Hospitals NHS Trust (UK)

No information available

Results and Publications

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

Editorial Notes

26/10/2015: no publications found on PubMed