Anti-reflux Control to Decrease Post Tonsillectomy Pain
Stopped early · Phase 4 · Has a placebo group
Conditions studied: Laryngopharyngeal Reflux, Throat Pain
In brief
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.
Key facts
- Study ID
- NCT01777854
- Run by
- Ascension Health
- People needed
- 6
- Starts
- 2013-01-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2018-10-24
Who can join
Age: 7 and older, up to 17. Sex: any. Healthy volunteers: accepted.
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 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
Where it is running
- Genesys Regional Medical Center — Grand Blanc, Michigan, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.