The Effects of Reducing Stomach Acid on Post-Tonsillectomy Pain

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Children's Hospital Boston.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT00472186
First received: May 10, 2007
Last updated: December 26, 2007
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Post-Tonsillectomy Pain
Post-Tonsillectomy Activity
Post-Tonsillectomy Hydration
Drug: Lansoprazole
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Gastro-Esophageal Acid Suppression on Post-Tonsillectomy Pain

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • The primary outcome is the number of days to become free of narcotic pain medication. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: December 2007
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Post-operative administration of Lansoprazole
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.
Other Name: Prevacid
Placebo Comparator: 2
Placebo
Drug: Placebo
Placebo will also be administered based on weight.

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

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472186

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

Locations
United States, Massachusetts
Children's Hospital Boston Not yet recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Manali Amin, MD         
Childrens Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Investigators
Principal Investigator: Manali Amin, MD Children's Hosptial Boston
  More Information

No publications provided

Responsible Party: Manali Amin, Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT00472186     History of Changes
Other Study ID Numbers: 06-11-0513
Study First Received: May 10, 2007
Last Updated: December 26, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Boston:
Tonsillectomy
Pain

Additional relevant MeSH terms:
Lansoprazole
Dexlansoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014