Overview

The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain

Status:
Terminated
Trial end date:
2011-02-01
Target enrollment:
0
Participant gender:
All
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 hypothesized that even a small amount of stomach acid backing up and entering the mouth can increase post-tonsillectomy pain. Therefore, the use of an antacid-like medication should help to decrease pain and reduce the amount of narcotic medication required for pain control.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Boston Children's Hospital
Boston Children’s Hospital
Treatments:
Dexlansoprazole
Lansoprazole
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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