Status:
TERMINATED
The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain
Lead Sponsor:
Boston Children's Hospital
Conditions:
Post-tonsillectomy Pain
Post-tonsillectomy Activity
Eligibility:
All Genders
5-18 years
Phase:
PHASE4
Brief Summary
This study was designed to determine whether post-operative pain following a tonsillectomy can be reduced by adding an antacid-like medication to the medications taken after surgery. It is hypothesize...
Detailed Description
This study has been limited to children and adolescents ages 5-18 who are undergoing tonsillectomy for an indication of obstructive sleep disturbance (snoring, choking/gasping or pauses in breathing d...
Eligibility Criteria
Inclusion
- All healthy children ages 5-18 years scheduled for tonsillectomy and /or adenotonsillectomy for sleep disturbance secondary to airway obstruction at Children's Hospital Boston
Exclusion
- Patients on any medications other than the study drug (Lansoprazole or placebo), Amoxicillin®, and acetaminophen with or without codeine
- An underlying medical condition which would necessitate an alteration in the anesthetic regimen
- Patients allergic to any of the medications in the protocol
- History of chronic tonsillitis
- History of chronic pain conditions
- History of active gastro-esophageal reflux disease
- Surgery in addition to tonsillectomy/adenotonsillectomy (except for myringotomy)
- Cognitive/developmental disorders
- Inability to use a self-report pain scale
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00472186
Start Date
June 1 2008
End Date
February 1 2011
Last Update
December 6 2021
Active Locations (2)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
2
Childrens Hospital Boston
Boston, Massachusetts, United States, 02115