Clinical trial NCT00472186: The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain
Official title: The Effects of Gastro-esophageal Acid Suppression on Post-tonsillectomy Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Post-tonsillectomy Pain
Post-tonsillectomy Activity
Post-tonsillectomy Hydration
Keywords: Tonsillectomy
Pain
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2007-05-11
Enrollment: 2
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: The Primary Outcome is the Number of Days to Become Free of Narcotic Pain Medication.
timeFrame: 2 weeks
Secondary outcomes:
measure: 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.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
city: Boston
country: United States
facility: Childrens Hospital Boston
state: Massachusetts
Study officials:
affiliation: Children's Hosptial Boston
name: Manali Amin, MD
role: PRINCIPAL_INVESTIGATOR
References: