Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Enhancin in Prevention of Postadenotonsillectomy Morbidity.
Not Applicable
Completed
- Conditions
- Adenotonsillar Hypertrophy,Under 12 Years.
- Interventions
- Drug: Enhancin
- Registration Number
- NCT01267942
- Lead Sponsor
- University of Nairobi
- Brief Summary
Null hypothesis; The efficacy of Enhancin\]Co-Amoxiclav given as a single intravenous dose at induction is not better than a five days oral course of the same given postoperatively in reducing postoperative morbidity after adenotonsillectomy.
- Detailed Description
Adenotonsillectomy results in morbidity that is reduced by the use of antibiotics.This study had the sole objective of comparing two route of administration to see which has superior results.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
Inclusion Criteria
- Patients below 12year scheduled to undergo adenotonsillectomy whose parents or guardians give consent for recruitment into the study.
Exclusion Criteria
- Non consenting parents or guardians. Antibiotic use in the week preceding surgery. Patients with co mordities. Known allergies to Co-amoxiclav. Patients who develop complication that warrant change of antibiotic.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Postoperative oral Enhancin. Enhancin Patients received postoperative oral Enhancin for five days in addition to oral Paracetamol for the same duration. They did not receive an antibiotic during the operation. Intravenous intraoperative Enhancin Enhancin Patients received a dose of intravenous Enhancin at induction and only oral Paracetamol in the postoperative period.
- Primary Outcome Measures
Name Time Method POSTOPERATIVE FEVER OPERATION DAY TO 7 DAYS POSTOPERATIVELY Temperature monitored at 1st ,4th and 7th postoperative days.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kenyatta National Hospital.
🇰🇪Nairobi., Kenya