The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain

Boston Children's Hospital

Status and phase: Terminated; Phase 4

Conditions: Post-tonsillectomy Pain; Post-tonsillectomy Hydration; Post-tonsillectomy Activity

Treatments: Drug: Placebo; Drug: Lansoprazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00472186

06-11-0513

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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2 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Post-operative administration of Lansoprazole

Treatment:

Drug: Lansoprazole

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo