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

University of Nairobi

Status: Completed

Conditions: Adenotonsillar Hypertrophy,Under 12 Years.

Treatments: Drug: Enhancin

Study type: Interventional

Funder types: Other

Identifiers

NCT01267942

P75/4/2008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: All

Ages: Under 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

Intravenous intraoperative Enhancin

Experimental group

Description:

Patients received a dose of intravenous Enhancin at induction and only oral Paracetamol in the postoperative period.

Treatment:

Drug: Enhancin

Postoperative oral Enhancin.

Active Comparator group

Description:

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.

Treatment:

Drug: Enhancin