Anti-reflux Control to Decrease Post Tonsillectomy Pain

NCT01777854 | Terminated Phase 4 Results

• 1 other identifier: GRMC 12 0020
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pain After Tonsillectomy

  A questionnaire will be given to patients. Patients are asked to describe their pain and oral intake on post op days 0,1,3,5,7,10 and 14. This should take less than one minute per assessment day. At the end of the survey, they are asked to comment on any postoperative problems such as hemorrhage or dehydration. This should take less than 5 minutes. Parents will be asked to assist the child in completing the survey. They will be asked to turn in the form on the postoperative follow up visit (14-21 days after surgery) or mail it in to the principal investigator if the surgeon does not have a postoperative follow up visit. For these patients, an addressed and stamped envelope will be provided.

  2 weeks

Study Arms (2)

Omeprazole

ACTIVE COMPARATOR

Yes. Omeprazole (generic) will be used. Children \>20 kg will be given 20 mg PO daily for 4 weeks prior to tonsillectomy. This is the normal standard pediatric dosing for reflux. Omeprazole is authorized to treat reflux in children. The study focuses on laryngopharyngeal reflux that possibly contributes to post tonsillectomy pain.

Drug: Omeprazole

Sugar pill

PLACEBO COMPARATOR

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.

Drug: Omeprazole

Interventions

Omeprazole DRUG

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.

Also known as: Prilosec, Prilosec OTC

Omeprazole; Sugar pill

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age 7-17 years old
• Weight \>20 kg
• Scheduled to undergo a tonsillectomy (with or without adenoidectomy) in greater than four weeks.
• Health conditions (any of the following): Hypertrophic tonsils and adenoids, sleep disordered breathing, obstructive sleep apnea, chronic or recurrent tonsillitis, halitosis, dysphagia
• Must be able to swallow pills or tolerate taking the medication sprinkled on applesauce or other soft food.

You may not qualify if:

• Age \<7
• Weight \<20kg
• Patients declared by the parent not able to communicate pain level.
• Patients with a mental illness. This will be determined by the patient's physician or the physician overseeing the care of the patient.
• Unable to swallow pills or tolerate sprinkling the medication on soft food.
• Pregnant patients
• Any patients already taking Proton Pump Inhibitor

Sponsors & Collaborators

• Ascension Health: lead

Study Sites (1)

Genesys Regional Medical Center

Grand Blanc, Michigan, 48439, United States

Location

MeSH Terms

Conditions

Laryngopharyngeal Reflux; Pharyngitis

Interventions

Omeprazole

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Laryngeal Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Carissa Wentland DO
• Organization: UH

carissa.wentland@gmail.com

320-392-4737

Study Officials

• Carissa J Wentland, DO

  Ascension Health

  PRINCIPAL INVESTIGATOR

• Kimberly Barber, PhD

  Ascension Health

  STUDY DIRECTOR

• Candy Rainwater

  Ascension Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DO/Otolaryngology Resident

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 29, 2013
• Study Start: January 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 24, 2018
• Results First Posted: September 25, 2018

Record last verified: 2018-09

Locations

US (1)