Anti-reflux Control to Decrease Post Tonsillectomy Pain

• Status: Terminated
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ascension Genesys Hospital; Genesys Regional Medical Center
• Treatments: Omeprazole

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 whose tonsillectomy is scheduled <4 weeks from the preoperative assessment (The patient would not have time to complete the preoperative treatment) (An exception to this exclusion criteria will be for the control group)

• 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