Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Enhancin in Prevention of Postadenotonsillectomy Morbidity.
This study has been completed.
Sponsor:
University of Nairobi
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
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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:
|
|
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:
|
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 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 June 13, 2013