Clinical trial NCT01777854: Anti-reflux Control to Decrease Post Tonsillectomy Pain
Official title: Anti-reflux Control to Decrease Post Tonsillectomy Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Laryngopharyngeal Reflux
Throat Pain
Lead sponsor: Ascension Health
Sponsor class: INDUSTRY
First posted: 2013-01-29
Enrollment: 6
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Pain After Tonsillectomy
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Grand Blanc
country: United States
facility: Genesys Regional Medical Center
state: Michigan
Study officials:
affiliation: Ascension Health
name: Carissa J Wentland, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Ascension Health
name: Kimberly Barber, PhD
role: STUDY_DIRECTOR
affiliation: Ascension Health
name: Candy Rainwater
role: STUDY_DIRECTOR
References: