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
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