Anti-reflux Control to Decrease Post Tonsillectomy Pain

NCT ID: NCT01777854

Last Updated: 2018-10-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-07-31

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.

Detailed Description

The study aims to determine if treating pediatric patients (age 7-18) 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 or placebo to be taken for the four weeks prior to tonsillectomy. The investigators will be blinded to the intervention. The medication will be kept in a locked drawer at the ENT Associates office. The patient will take the medication 20 mg orally once a day for 28 days prior to the procedure with day 28 being the day before the tonsillectomy. The patient will be provided with a calender that is marked with the start date of the medication. The patient is to document any missed doses on the calender. On the day of surgery, the patient will return the remainder of the medication in an opaque bag along with the calender and this will be given back to the research pharmacist to account for the medication.

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 (2 weeks after the surgery) 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.

Other variables collected will be patient age, gender, method of surgery, pain medication prescribed, and indication for procedure. The data will be stored in a password protected computer files and the patient will only be identified by study number.

Conditions

Laryngopharyngeal Reflux; Throat Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Omeprazole

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.

Group Type: ACTIVE_COMPARATOR

Omeprazole

Intervention Type: 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.

Sugar pill

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.

Group Type: PLACEBO_COMPARATOR

Omeprazole

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Prilosec, Prilosec OTC

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ascension Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Carissa Wentland DO

DO/Otolaryngology Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carissa J Wentland, DO

Role: PRINCIPAL_INVESTIGATOR

Ascension Health

Kimberly Barber, PhD

Role: STUDY_DIRECTOR

Ascension Health

Candy Rainwater

Role: STUDY_DIRECTOR

Ascension Health

Locations

Genesys Regional Medical Center

Grand Blanc, Michigan, United States

Countries

United States

Other Identifiers

GRMC 12 0020

Identifier Type: -

Identifier Source: org_study_id