post-operative course of dexamethasone to reduce tonsillectomy morbidity

Conditions: Adenotonsillectomy; Analgesia; Surgery

Summary: the goal of this study is determine if an oral systemic course of steroids is a safe and effective option in lowering pain and complications following adenotonsillectomy in various pediatric age groups. a double blind, placebo-controlled randomized clinical trial of steroids (dexamethasone) versus placebo postoperatively will be performed. investigators will determine if there is a difference in post-operative pain and complications between groups.

purpose: to determine if post-operative dexamethasone is a safe and effective option in the reduction of post-operative pain and morbidity following adenotonsillectomy in various pediatric age groups. methods: the subject population will be patients between the ages of 3 and 17 who will undergo adenotonsillectomy. the study will consist of two double-blinded arms - patients receiving a course of oral dexamethasone (doses on post-operative days 2, 4, and 6; 0.5 mg/kg; max dose: 20 mg) in addition to standard pain control regimen and patients receiving an oral placebo course in addition to standard pain control regimen. in the diary they will receive, patients or caregivers will record when specific pain medications were taken each day, a symptoms survey, and pain ratings measured by the wong-baker faces pain rating scale. patients are able to return their diary at a post-operative appointment at chp main, through email by scanning the diary or taking pictures with their phone, or through mailing in the survey in a pre-stamped envelope. demographic information such as age, race, gender, and household income will be extracted from the diary and the electronic medical record. information such as surgical technique, concurrent operations, post-operative pain prescription (types, weight based dosage, and total days prescribed) will be extracted from the electronic medical record and recorded as well. outcomes measured will include pain scale rating and rates of complications between the two groups. significance: if it can be demonstrated that dexamethasone after adenotonsillectomy can reduce pain, complications, or need for opioid analgesics without appreciable side effects, a strong argument can be made for the addition of this inexpensive medication to routine post-operative adenotonsillectomy care. this would help with limiting the burden of clinical course of tonsillectomy. the primary and secondary outcome measures were refined prior to analysis. originally, the primary outcome measure was "average pain burden" defined as "average pain over 14 post-operative days before and after medications." however, study medication was not administered until day 2, and the power analysis was based on a study by palme et al (2000) that compared mean pain ratings on postoperative days 2-8. therefore, the primary outcome was revised to "average pain over 2-8 post-operative days before medications." average pain over 2-8 post-operative after medications was added as a secondary outcome. the original primary outcome combined analysis of pain before and after medication into one measure. however, pain scores were more commonly reported prior to medication than after. due to missing post-medication scores, it was determined that the analysis would be more appropriately conducted separately for pain scores before and after medication.

Eligibility criteria:
inclusion criteria: * patients age 3 - 17 undergoing adenotonsillectomy meet inclusion criteria exclusion criteria: * patients with down syndrome * patients with a history of coagulopathy * patients with craniofacial abnormalities other than plagiocephaly or submucous cleft palate (smcp) * caregivers who cannot speak, read, or write in english proficiently * patients who take systemic corticosteroids during the enrollment period * patients who take opioids during the enrollment period * patients who take chronic opioids * patients who are pregnant * patients with allergy to or contraindication for taking any of the study medications * patients who have the inability to communicate * patients who have the inability to localize pain * patients who have type 1 diabetes * patients who have type 2 diabetes

Keywords: pediatric otolaryngology steroid placebo post-operative pain