Anti-reflux Control to Decrease Post Tonsillectomy Pain
Status:
Terminated
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
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
Details
Lead Sponsor:
Ascension Genesys Hospital Genesys Regional Medical Center