Official Title: “The Effects of Gastro-Esophageal Acid Suppression on Post-Tonsillectomy Pain”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment

Study Primary Completion Date: May 2009

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Post-operative administration of Lansoprazole
• Placebo Comparator: 2
  • Placebo

Primary Measures

• The primary outcome is the number of days to become free of narcotic pain medication.
  • Time Frame: 2 weeks
    Safety Issue?: No

Secondary Measures

• The secondary outcomes are the number of days to be free of pain, the number od days to return to normal activity levels and the number of days to return to normal fluid intake.
  • Time Frame: 2 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 5 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Children's Hospital Boston

Overall Clinical Trial Officials and Contacts

Manali Amin, MD Principal Investigator Children's Hosptial Boston  

Overall Contact: Manali Amin, MD 617-355-5116 manali.amin@childrens.harvard.edu

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00472186

Study ID Number: 06-11-0513

ClinicalTrials.gov Identifier: NCT00472186

Health Authority: United States: Institutional Review Board