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 |
| Protocol serial number | N0185088382 |
| Sponsor | Department of Health (UK) |
| Funder | Plymouth Hospitals NHS Trust (UK) |
- 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
Scientific
Anaesthetic Department
Level 04
Derriford Hospital
Derriford
Plymouth
PL6 8DH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Morphine, fentanyl |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 15/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| 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
- United Kingdom
- England
Study participating centre
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
26/10/2015: no publications found on PubMed
