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The Effects of Reducing Stomach Acid on Post-tonsillectomy Pain

NCT ID: NCT00472186

Last Updated: 2021-12-06

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Keywords

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Tonsillectomy Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

Post-operative administration of Lansoprazole

Group Type EXPERIMENTAL

Lansoprazole

Intervention Type 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.

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will also be administered based on weight.

Interventions

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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.

Intervention Type DRUG

Placebo

Placebo will also be administered based on weight.

Intervention Type DRUG

Other Intervention Names

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Prevacid

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Manali Amin

Instructor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Manali Amin, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hosptial Boston

Locations

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Children's Hospital Boston

Boston, Massachusetts, United States

Site Status

Childrens Hospital Boston

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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06-11-0513

Identifier Type: -

Identifier Source: org_study_id