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

Adenotonsillar Hypertrophy,Under 12 Years. Clinical Trial

Official title:

Single Intraoperative Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Full Oral Course in Prevention of Post Adenotonsillectomy Morbidity:A Randomised Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01267942
• Other study ID #: P75/4/2008
• Status: Completed
• Phase: N/A
• First received: December 28, 2010
• Last updated: December 28, 2010
• Start date: May 2008
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: University of Nairobi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Kenya: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: October 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Adenotonsillar Hypertrophy,Under 12 Years.
• Hypertrophy

Intervention

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.

Locations

Country	Name	City	State
Kenya	Kenyatta National Hospital.	Nairobi.

Sponsors (1)

Lead Sponsor	Collaborator
University of Nairobi

Country where clinical trial is conducted

Kenya, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	POSTOPERATIVE FEVER	Temperature monitored at 1st ,4th and 7th postoperative days.	OPERATION DAY TO 7 DAYS POSTOPERATIVELY	No