The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain

NCT00472186 | Terminated Phase 4 Results DMC

• 1 other identifier: 06-11-0513
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Post-tonsillectomy Pain; Post-tonsillectomy Activity; Post-tonsillectomy Hydration

Keywords

Tonsillectomy; Pain

Outcome Measures

Primary Outcomes (1)

• The Primary Outcome is the Number of Days to Become Free of Narcotic Pain Medication.

  2 weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

1

EXPERIMENTAL

Post-operative administration of Lansoprazole

Drug: Lansoprazole

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Lansoprazole DRUG

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.

Also known as: Prevacid

1

Placebo DRUG

Placebo will also be administered based on weight.

2

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (2)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Childrens Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Manali Amin, MD
• Organization: Dupage Chidlren's ENT & Allergy

manali.amin@gmail.com

630-785-0367

Study Officials

• Manali Amin, MD

  Children's Hosptial Boston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: May 10, 2007
• First Posted: May 11, 2007
• Study Start: June 1, 2008
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: December 6, 2021
• Results First Posted: December 6, 2021

Record last verified: 2021-11

Locations

US (2)