The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain

Phase 4

Terminated

Conditions: Post-tonsillectomy Pain
Post-tonsillectomy Activity
Post-tonsillectomy Hydration

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 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.

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 during sleep.)

Study participants will be randomized to two groups: study medication (Lansoprazole) or an inactive substance(placebo).

Participants will be asked to do all of the following:

1. Take the study medication twice a day for 14 days.

2. Keep a log book which will include:

* Record the medications and amount of each medication taken each day for 14 days. This includes pain medication and the study drug.

* Record your child's activity level daily for 14 days.

* Collect your child's urine one time daily and test it using special medicated strips to monitor their daily liquid intake for 14 days.

3. Meet with a Research Assistant or Study Physician 14-21 days after the study to collect the log book and perform a post-operative examination.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo
1	Lansoprazole	Post-operative administration of Lansoprazole

Primary Outcome Measures

Name	Time	Method
The Primary Outcome is the Number of Days to Become Free of Narcotic Pain Medication.	2 weeks

Secondary Outcome Measures

Name	Time	Method
The Secondary Outcomes Are the Number of Days to be Free of Pain, the Number of Days to Return to Normal Activity Levels and the Number of Days to Return to Normal Fluid Intake.	2 weeks

Locations (2): Childrens Hospital Boston
🇺🇸
Boston, Massachusetts, United States
Children's Hospital Boston
🇺🇸
Boston, Massachusetts, United States