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The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain

This study has been terminated.
(Poor compliance with returning of logbooks by families. Two patients were enrolled. Only one returned the logbook and therefore not analyzed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00472186
First Posted: May 11, 2007
Last Update Posted: September 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Manali Amin, Boston Children's Hospital
  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: Triple (Participant, Care Provider, 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 Manali Amin, Boston Children's Hospital:

Primary Outcome Measures:
  • The primary outcome is the number of days to become free of narcotic pain medication. [ Time Frame: 2 weeks ]

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 ]

Enrollment: 2
Actual Study Start Date: June 2008
Study Completion Date: February 2011
Primary Completion Date: February 2011 (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

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00472186


Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Childrens Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children’s Hospital
Investigators
Principal Investigator: Manali Amin, MD Children's Hosptial Boston
  More Information

Responsible Party: Manali Amin, Instructor, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT00472186     History of Changes
Other Study ID Numbers: 06-11-0513
First Submitted: May 10, 2007
First Posted: May 11, 2007
Last Update Posted: September 21, 2017
Last Verified: September 2017

Keywords provided by Manali Amin, Boston Children's Hospital:
Tonsillectomy
Pain

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