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The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain

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ClinicalTrials.gov Identifier: NCT00472186
Recruitment Status : Terminated (Poor compliance with returning of logbooks by families. Two patients were enrolled. Only one returned the logbook and therefore not analyzed)
First Posted : May 11, 2007
Last Update Posted : September 21, 2017
Sponsor:
Information provided by (Responsible Party):

May 10, 2007
May 11, 2007
September 21, 2017
June 2008
February 2011   (Final data collection date for primary outcome measure)
The primary outcome is the number of days to become free of narcotic pain medication. [ Time Frame: 2 weeks ]
The primary outcome is the number of days to become free of narcotic pain medication.
Complete list of historical versions of study NCT00472186 on ClinicalTrials.gov Archive Site
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 ]
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.
Not Provided
Not Provided
 
The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain
The Effects of Gastro-esophageal Acid Suppression on Post-tonsillectomy Pain
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.

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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Post-tonsillectomy Pain
  • Post-tonsillectomy Activity
  • Post-tonsillectomy Hydration
  • 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
  • Drug: Placebo
    Placebo will also be administered based on weight.
  • Experimental: 1
    Post-operative administration of Lansoprazole
    Intervention: Drug: Lansoprazole
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
February 2011
February 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
5 Years to 18 Years   (Child, Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00472186
06-11-0513
Yes
Not Provided
Not Provided
Manali Amin, Boston Children's Hospital
Boston Children’s Hospital
Not Provided
Principal Investigator: Manali Amin, MD Children's Hosptial Boston
Boston Children’s Hospital
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP