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

NCT ID: NCT01267942

Last Updated: 2010-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-10-31

Brief Summary

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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

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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.

Conditions

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Adenotonsillar Hypertrophy,Under 12 Years.

Keywords

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Adenotonsillectomy.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intravenous intraoperative Enhancin

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

Group Type EXPERIMENTAL

Enhancin

Intervention Type DRUG

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.

Postoperative oral 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.

Group Type ACTIVE_COMPARATOR

Enhancin

Intervention Type DRUG

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.

Interventions

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Enhancin

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.

Intervention Type DRUG

Other Intervention Names

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Augmentin. Clavulin. Myoclav. Co- amoxiclav

Eligibility Criteria

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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.
Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nairobi

OTHER

Sponsor Role lead

Responsible Party

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University of Nairobi.

Principal Investigators

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Musyoka D Mutiso, mmed ent

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, Kenya

Locations

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Kenyatta National Hospital.

Nairobi, Nairobi County, Kenya

Site Status

Countries

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Kenya

References

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Colreavy MP, Nanan D, Benamer M, Donnelly M, Blaney AW, O'Dwyer TP, Cafferkey M. Antibiotic prophylaxis post-tonsillectomy: is it of benefit? Int J Pediatr Otorhinolaryngol. 1999 Oct 15;50(1):15-22. doi: 10.1016/s0165-5876(99)00228-1.

Reference Type BACKGROUND
PMID: 10596882 (View on PubMed)

Mutiso MD, Macharia IM. Single intraoperative intravenous Co-Amoxiclav versus postoperative full oral course in prevention of postadenotonsillectomy morbidity: a randomised clinical trial. BMC Ear Nose Throat Disord. 2011 Sep 30;11:9. doi: 10.1186/1472-6815-11-9.

Reference Type DERIVED
PMID: 21961644 (View on PubMed)

Other Identifiers

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P75/4/2008

Identifier Type: -

Identifier Source: org_study_id