A randomised controlled trial of two analgesic techniques for the control of pain and post-operative nausea and vomiting in paediatric day-case tonsillectomy. - RCT of two analgesic techniques for day-case tonsillectomy.

Conditions: Tonsillectomy is one of the most common surgical procedures in children and is usually associated with moderate to severe pain which is problematic to treat because of side effects associated with the analgesics. Government targets include increasing day-case tonsillectomy We use codeine for analgesia. We wish to compare this wih the Bristol group who found a low incidence of postoperative nausea and vomiting using fentanyl.

Registration Number: EUCTR2007-007625-43-GB

Lead Sponsor: Birmingham Children’s Hospital NHS Foundation Trust

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

All ASA I or II children aged 4 -16 years scheduled for elective tonsillectomy or adenotonsillectomy +/-grommets and suitable for day-case surgery will be invited to enter the study.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Children involved in other studies or who have been involved in other studies in the previous year.
Sensitivity to any of the study drugs.
Bleeding diathesis and renal or hepatic impairment.
Children with developmental delay, behavioural problems (autism etc.) in whom pain assessment would be difficult.
Children with parents that don’t speak/understand English making informed consent difficult.
Children in whom obtaining informed consent is difficult for any other reason.
Children requiring premedication (as this may affect the pain and sedation levels in the early postoperative period).
•Children who have taken any analgesic drugs on the day of surgery.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: In children having tonsillectomy does a technique using fentanyl and diclofenac for pain relief reduce the incidence of postoperative nausea and vomiting (without compromising pain control) when compared to a technique using codeine phosphate as the pain killer?;Secondary Objective: ;Primary end point(s): Postoperative nausea and vomiting in the first 4 hours (yes or no)

Secondary Outcome Measures