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.

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.

Study Overview

• Status: Completed
• Conditions: Adenotonsillar Hypertrophy,Under 12 Years.
• Intervention / Treatment: Drug: Enhancin

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Nairobi., Kenya, P.O.BOX 20723
    • Kenyatta National Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
POSTOPERATIVE FEVER	Temperature monitored at 1st ,4th and 7th postoperative days.	OPERATION DAY TO 7 DAYS POSTOPERATIVELY

Collaborators and Investigators

• Sponsor: University of Nairobi
• Investigators: Principal Investigator: Musyoka D Mutiso, mmed ent, Ministry of Health, Kenya

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): October 1, 2008
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: December 28, 2010
• First Submitted That Met QC Criteria: December 28, 2010
• First Posted (Estimate): December 29, 2010

Study Record Updates

• Last Update Posted (Estimate): December 29, 2010
• Last Update Submitted That Met QC Criteria: December 28, 2010
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Adenotonsillectomy.
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: P75/4/2008