NCT00472186

The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Boston Children's Hospital · Academic / Other
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Post-tonsillectomy Pain
• Post-tonsillectomy Activity
• Post-tonsillectomy Hydration

Interventions

Type	Name	Description
DRUG	Lansoprazole	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.
DRUG	Placebo	Placebo will also be administered based on weight.

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2007-05-11
• Last updated: 2021-12-06
• Results posted: 2021-12-06

Locations

2 sites across 1 country: United States