Kenyatta National Hospital.
Nairobi, Nairobi County, P.O.BOX 20723, Kenya
Completed
NCT Number: NCT01267942
Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Enhancin in Prevention of Postadenotonsillectomy Morbidity.
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.
Completed
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Notify MeKey information
Conditions
Age range
Up to 12 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Enhancin
DrugIntravenous Enhancin at induction at a dose of 25 mg/kg amoxycillin equivalent.
Oral dose of the same at the same dosage for the active comparator arm.
Other names: Augmentin., Clavulin., Myoclav., Co- amoxiclav
Primary outcomes
-
POSTOPERATIVE FEVER
Time frame: OPERATION DAY TO 7 DAYS POSTOPERATIVELY
Temperature monitored at 1st ,4th and 7th postoperative days.
Sponsors and collaborators
Lead sponsor
University of Nairobi
Other
Registry information
Official study title
Single Intraoperative Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Full Oral Course in Prevention of Post Adenotonsillectomy Morbidity:A Randomised Clinical Trial.
Important dates
- Study start
- 2008
- Primary completion
- 2008
- Study completion
- 2009
- First posted
- Dec 29, 2010
- Registry last updated
- Dec 29, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.