Anti-reflux Control to Decrease Post Tonsillectomy Pain

Summary

The study aims to determine if treating pediatric patients (age 7-17) for four weeks with omeprazole prior to tonsillectomy will decrease post tonsillectomy pain. The hypothesis is that many patients have silent laryngopharyngeal reflux and by reducing the acid entrance into the oropharynx, patients will have less post tonsillectomy pain due to decreased acid irritation of the surgical wound (tonsil fossas).

The study will be a prospective double blind randomized study. Participants will be invited to participate in the study by giving the study information at the preoperative assessment, when the decision is made to have a tonsillectomy performed. If the patient agrees to participate in the study, a written consent and child assent will be obtained and the patient will be randomly assigned to a treatment versus control group based on the randomly assigned participant number.

The treatment group will then be given a four week course of omeprazole to be taken for the four weeks prior to tonsillectomy. The patient will be given a post tonsillectomy assessment form. The form looks at postoperative pain (using a visual analog scale 1-10) as well as oral intake at postoperative day 0,1,3,5,7,10, and 14. The form will be turned in at the postoperative visit or mailed in.

The pain level and oral intake between the two groups to will be compared to determine if antireflux control helps decrease the postoperative pain after tonsillectomy.

Conditions

• Laryngopharyngeal Reflux
• Throat Pain

Interventions

DRUG

Omeprazole

The principal investigator will be contacted and will work with the research pharmacist to obtain the omeprazole (20 mg PO daily for patients \>20kg) and placebo. The placebo does not look like the omeprazole, however this will not be an issue because none of the subjects will have knowledge of how the medications look. The medication will be locked in the designated medication cabinet at each office. It will be prepackaged for a 28 day course. The patient will start the treatment 4 weeks prior to tonsillectomy and stop the day before surgery. The medication will be given to the patient once the consent and assent are signed. This will avoid an unnecessary office visit to improve patient compliance.

Sponsors & Collaborators

• Ascension Health

  lead INDUSTRY

Principal Investigators

• Carissa J Wentland, DO · Ascension Health

• Kimberly Barber, PhD · Ascension Health

• Candy Rainwater · Ascension Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2015-07-31

Completion

2015-07-31

Countries

• United States

Study Locations