Abstract
The vast majority of placebos are administered with concealment or deception. Most clinicians and researchers believe that either deception or concealment is necessary to achieve a placebo response; however, recent studies with open-label placebo (OLP), conditioning, and conditioning + OLP (COLP) have shown that placebos can be effective even when patients know they are receiving a placebo. To date, no studies have examined COLP in a pediatric surgical population, which is vulnerable to developing opioid dependence. COLP may assist in lowering opioid doses administered and quicker tapering off opioids. This study investigates the effectiveness of COLP on postoperative treatment of patients ages 10 through 17 undergoing posterior fusion for adolescent idiopathic scoliosis (AIS). It is a randomized controlled trial of 64 AIS patients assigned to one of the two arms: COLP + treatment as usual (TAU) and TAU control. Randomization and baseline assessments occur at the preoperative visit. Opioid consumption is recorded weekly after hospitalization until the first in-person postoperative visit at 6 weeks. The primary outcome measure is postoperative opioid consumption, both amount and duration. Secondary outcomes include pain, functional ability, and mental health scores.