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

This study has been completed.
Sponsor:
Information provided by:
University of Nairobi
ClinicalTrials.gov Identifier:
NCT01267942
First received: December 28, 2010
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

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.


Condition Intervention
Adenotonsillar Hypertrophy,Under 12 Years.
Drug: Enhancin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Single Intraoperative Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Full Oral Course in Prevention of Post Adenotonsillectomy Morbidity:A Randomised Clinical Trial.

Further study details as provided by University of Nairobi:

Primary Outcome Measures:
  • POSTOPERATIVE FEVER [ Time Frame: OPERATION DAY TO 7 DAYS POSTOPERATIVELY ] [ Designated as safety issue: No ]
    Temperature monitored at 1st ,4th and 7th postoperative days.


Enrollment: 126
Study Start Date: May 2008
Study Completion Date: October 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravenous intraoperative Enhancin
Patients received a dose of intravenous Enhancin at induction and only oral Paracetamol in the postoperative period.
Drug: 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.

Other Names:
  • Augmentin.
  • Clavulin.
  • Myoclav.
  • Co- amoxiclav
Active Comparator: 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.
Drug: 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.

Other Names:
  • Augmentin.
  • Clavulin.
  • Myoclav.
  • Co- amoxiclav

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.

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01267942

Locations
Kenya
Kenyatta National Hospital.
Nairobi., Kenya, P.O.BOX 20723
Sponsors and Collaborators
University of Nairobi
Investigators
Principal Investigator: Musyoka D Mutiso, mmed ent Ministry of Health, Kenya
  More Information

Publications:
Responsible Party: ISSAC MUTHURE MACHARIA/PROFESSOR., University of Nairobi.
ClinicalTrials.gov Identifier: NCT01267942     History of Changes
Other Study ID Numbers: P75/4/2008
Study First Received: December 28, 2010
Last Updated: December 28, 2010
Health Authority: Kenya: Ministry of Health

Keywords provided by University of Nairobi:
Adenotonsillectomy.

Additional relevant MeSH terms:
Hypertrophy
Pathological Conditions, Anatomical
Amoxicillin-Potassium Clavulanate Combination
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 21, 2014