Back to resultsIntravenous Enhancin[Co-amoxiclav] Versus Postoperative Enhancin in Prevention of Postadenotonsillectomy Morbidity.
Primary Purpose
Adenotonsillar Hypertrophy,Under 12 Years.
Status
Completed
Phase
Not Applicable
Locations
Kenya
Study Type
Interventional
Intervention
Enhancin
Sponsored by
About this trial
This is an interventional prevention trial for Adenotonsillar Hypertrophy,Under 12 Years. focused on measuring Adenotonsillectomy.
Eligibility 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.
Sites / Locations
- Kenyatta National Hospital.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intravenous intraoperative Enhancin
Postoperative oral Enhancin.
Arm Description
Patients received a dose of intravenous Enhancin at induction and only oral Paracetamol in the postoperative period.
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.
Outcomes
Primary Outcome Measures
POSTOPERATIVE FEVER
Temperature monitored at 1st ,4th and 7th postoperative days.
Secondary Outcome Measures
Full Information
NCT ID
NCT01267942
First Posted
December 28, 2010
Last Updated
December 28, 2010
Sponsor
University of Nairobi
1. Study Identification
Unique Protocol Identification Number
NCT01267942
Brief Title
Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Enhancin in Prevention of Postadenotonsillectomy Morbidity.
Official Title
Single Intraoperative Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Full Oral Course in Prevention of Post Adenotonsillectomy Morbidity:A Randomised Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Nairobi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenotonsillar Hypertrophy,Under 12 Years.
Keywords
Adenotonsillectomy.
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
126 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intravenous intraoperative Enhancin
Arm Type
Experimental
Arm Description
Patients received a dose of intravenous Enhancin at induction and only oral Paracetamol in the postoperative period.
Arm Title
Postoperative oral Enhancin.
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Enhancin
Other Intervention Name(s)
Augmentin., Clavulin., Myoclav., Co- amoxiclav
Intervention Description
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.
Primary Outcome Measure Information:
Title
POSTOPERATIVE FEVER
Description
Temperature monitored at 1st ,4th and 7th postoperative days.
Time Frame
OPERATION DAY TO 7 DAYS POSTOPERATIVELY
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Musyoka D Mutiso, mmed ent
Organizational Affiliation
Ministry of Health, Kenya
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kenyatta National Hospital.
City
Nairobi.
ZIP/Postal Code
P.O.BOX 20723
Country
Kenya
12. IPD Sharing Statement
Citations:
PubMed Identifier
10596882
Citation
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.
Results Reference
background
PubMed Identifier
21961644
Citation
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.
Results Reference
derived
Learn more about this trial
Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Enhancin in Prevention of Postadenotonsillectomy Morbidity.
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