The Effects of Reducing Stomach Acid on Post-Tonsillectomy Pain

Condition(s) targeted: Post-Tonsillectomy Pain; Post-Tonsillectomy Activity; Post-Tonsillectomy Hydration

Intervention: Lansoprazole (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Children's Hospital Boston

Official(s) and/or principal investigator(s):
Manali Amin, MD, Principal Investigator, Affiliation: Children's Hosptial Boston

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

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.

Official title: The Effects of Gastro-Esophageal Acid Suppression on Post-Tonsillectomy Pain

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

Primary outcome: The primary outcome is the number of days to become free of narcotic pain medication.

Secondary outcome: 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.

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.

Minimum age: 5 Years. Maximum age: 18 Years. Gender(s): Both.

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

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

Children's Hospital Boston, Boston, Massachusetts 02115, United States; Not yet recruiting
Manali Amin, MD, Principal Investigator

Childrens Hospital Boston, Boston, Massachusetts 02115, United States; Recruiting

Starting date: December 2007
Ending date: May 2009
Last updated: December 26, 2007