The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain

Post-tonsillectomy Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00472186
• Other study ID #: 06-11-0513
• Status: Terminated
• Phase: Phase 4
• Start date: June 2008
• Est. completion date: February 2011

Study information

• Verified date: November 2021
• Source: Boston Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• Placebo
Placebo will also be administered based on weight.

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Childrens Hospital Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Outcome is the Number of Days to Become Free of Narcotic Pain Medication.		2 weeks
Secondary	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.		2 weeks