Clinical trial NCT01777854
Conditions: Laryngopharyngeal Reflux Throat Pain
Sponsor: Ascension Health
Start date: 2013-01-01; Completion date: 2015-07-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: 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. arm 2: 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.
Interventions: intervention 1: Omeprazole
Intervention descriptions: intervention 1: 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.

Protocol documents: