The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain

Study Overview
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Brief Summary
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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
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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: Take the study medication twice a day for 14 days. 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. 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.

Official Title
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The Effects of Gastro-esophageal Acid Suppression on Post-tonsillectomy Pain

Conditions
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Post-tonsillectomy Pain, Post-tonsillectomy Activity, Post-tonsillectomy Hydration

Intervention / Treatment
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* Drug: Lansoprazole
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Post-operative administration of Lansoprazole | Drug: Lansoprazole<br>* If weight is less than 30 kg, 15 mg of Lansoprazole twice daily will be administered. If weight is greater than or equal to 30 kg, 30 mg of Lansoprazole twice daily will be administered.<br>* Other names: Prevacid;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* Placebo will also be administered based on weight.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Primary Outcome is the Number of Days to Become Free of Narcotic Pain Medication. |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tonsillectomy, Pain