Post-operative Oral Corticosteroids Following Tonsillectomy: A Randomized Controlled Trial

I. Background

Tonsillectomy is one of the most common surgical procedures in the United States with the predominant indications being obstructive sleep apnea and recurrent tonsillitis1. While it is usually performed on young and otherwise healthy children, postoperative morbidity is ubiquitous occurring in nearly 20% of children with the most frequent complaints being throat pain, otalgia, fever, poor oral intake, nausea and emesis, and secondary hemorrhage2. Historically, Tylenol with codeine was commonly used for pain control post-operatively in children. However, in 2013 the FDA issued a black box warning on codeine following tonsillectomy due to reports of multiple deaths and morbidities in children3. Since that time, there has been increased awareness of the dangers of opioids in general and many surgeons are trying to minimize or eliminate the prescription of opioids to children following tonsillectomy.

It has been found by multiple studies that intra-operative use of steroids during tonsillectomy has beneficial effects in children. A Cochrane Review updated in 2011 presented a meta-analysis of 19 randomized, placebo-controlled, double blinded studies and concluded that routine use of a single intra-operative dose of dexamethasone reduces post-operative morbidity. The studies found a decrease in post-operative emesis and a higher likelihood of advancement to a soft or solid diet on the first postoperative day. Eight of the studies used the Visual Analog Scale (ranging from 0-10), which found a reduction of post-operative pain of more than one point. No adverse effects related to intra-operative corticosteroid use were reported and a single dose of steroids is believed to be virtually harmless4. Despite the utility of corticosteroids intra-operatively, there is currently a paucity of studies investigating the potential effects of a short post-operative course of oral (PO) steroids on pain control and other morbidities of tonsillectomy. Of the available literature, a short course of prednisolone of up to 1 week in patients without specific contraindications was found to provide a significant benefit in pain relief, return to normal diet, return to normal activity, and re-epithelialization of the tonsillar fossae, in an assessment of 69 pediatric patients5. Another study by Macassey et al. compared 5 days of oral prednisolone to placebo by assessing pain, nausea, vomiting, return to normal function, and sleep duration and quality. This study did not find a difference in any of the study parameters between the two groups6. To our knowledge, there have been no studies specifically looking at how the addition of a post-operative course of oral steroids impacts patient's necessity for narcotic pain medications.

Due to conflicting reports and a general paucity of literature to support or refute routine postoperative steroid use in children following tonsillectomy, it will be useful to determine the efficacy of this otherwise ubiquitous and benign medication on pain control, time to return to normal diet, dehydration, post-operative infections, and post-operative bleeding in our patient cohort; these are the most common complaints and complications following tonsillectomy surgery. Therefore, similar to the above-referenced studies5,6 we will be evaluating all of these endpoints in our patients. However, in addition to these endpoints we will also look at the need for post-operative narcotics. Given the recent black box warning on Tylenol with codeine use in children following tonsillectomy3, many surgeons are understandably hesitant to prescribe any narcotics to children following tonsillectomy. Our study will evaluate the potential role of steroids to reduce or possibly even eliminate the need to prescribe these children narcotics.

II. Objectives