The Effects of Reducing Stomach Acid on Post-Tonsillectomy Pain - Full Text View

Sponsor:	Children's Hospital Boston
Information provided by:	Children's Hospital Boston
ClinicalTrials.gov Identifier:	NCT00472186

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
Official Title:	The Effects of Gastro-Esophageal Acid Suppression on Post-Tonsillectomy Pain

Resource links provided by NLM:

MedlinePlus related topics: Tonsils and Adenoids

Drug Information available for: Lansoprazole

U.S. FDA Resources

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
1: Experimental 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.
2: Placebo Comparator 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:

Take the study medication twice a day for 14 days.
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.
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

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

Keywords provided by Children's Hospital Boston:

Tonsillectomy
Pain

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Lansoprazole
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010