Anti-reflux Control to Decrease Post Tonsillectomy Pain
Condition: Laryngopharyngeal Reflux; Throat Pain
MeSH terms: Gastroesophageal Reflux; Laryngopharyngeal Reflux
Intervention: Omeprazole
Intervention description: 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 MeSH terms: Omeprazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

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.
    

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