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Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Enhancin in Prevention of Postadenotonsillectomy Morbidity.

Single Intraoperative Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Full Oral Course in Prevention of Post Adenotonsillectomy Morbidity:A Randomised Clinical Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01267942
Enrollment
126
Registered
2010-12-29
Start date
2008-05-31
Completion date
2009-10-31
Last updated
2010-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenotonsillar Hypertrophy,Under 12 Years.

Keywords

Adenotonsillectomy.

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.

Interventions

DRUGEnhancin

Intravenous 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.

Sponsors

University of Nairobi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
POSTOPERATIVE FEVEROPERATION DAY TO 7 DAYS POSTOPERATIVELYTemperature monitored at 1st ,4th and 7th postoperative days.

Countries

Kenya

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026