Effectiveness of Conditioning + Open-label Placebo for the Management of Pain in Children Who Undergo Surgical Treatment of Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- The total amount of opioids consumed in oral morphine equivalents (OMEs) following surgery
研究概览
简要总结
This study aims to investigate the effects of conditioning with open-label placebos on standard postoperative treatment for patients undergoing surgery for idiopathic scoliosis in a randomized controlled, 6-week trial with 64 AIS patients randomly assigned to one of two arms: Open-label Placebo (COLP) + treatment as usual TAU / TAU control. The study involves collecting data from your child's medical record. At each regular clinic visit, the patient clinical data will be collected by the research coordinator. Surveys will be collected including:• PROMIS for the age group 10 to 18 years.
详细描述
Interventional (clinical trial): Subject will be randomly assigned using permuted blocks (block size of 4). Before usage, random assignments will be created, stored in sealed envelopes, and numbered (1, 2, etc.). There will be stratified randomization: Later on, stratification will be incorporated into the analysis. 32 people will be in the group taking the placebo pills in addition to standardized treatment and 32 people will be in the group with standardized treatment alone.
Hypothesis: Open-label Placebo (COLP) < treatment as usual (TAU) control. Secondary Aims Analysis Plan: There are three secondary aims in this study.
Aim 1. To determine whether 6 weeks of Open-label Placebo (COLP) results in significantly reduced opioid consumption compared to treatment as usual. To test this aim, the investigators will conduct a t-test comparing mean opioid use over the 6 weeks of follow up. In secondary analyses, the investigators will adjust for any baseline factors including gender, age, symptom severity or type of surgery that could be a confounding variable.
1a. To determine if 6 weeks of Open-label Placebo (COLP) results in reduced opioid consumption compared to treatment as usual. Hypothesis: Open-label Placebo (COLP) < treatment as usual (TAU) control.
Secondary Aims Analysis Plan: There are three secondary aims in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Blinding of patients and providers will not be feasible due to the nature of the study.
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible for enrollment, patients must meet all of the following inclusion criteria:
- •Diagnosis of idiopathic spine deformity.
- •Age >10 and <18 years.
- •Primary procedure.
- •Guardian provides signed and dated informed consent and understand the nature of the study sufficiently to allow completion of all study assessments.
- •Patient provides assent.
- •Fusion and fusionless instrumented spine surgery.
排除标准
- •If any of the following exclusion criteria are met, the patient is not eligible for the study:
- •Non-idiopathic scoliosis, such as neuromuscular or syndrome.
- •Revision procedure.
- •Self-reported pregnancy or planned pregnancy within the next two months.
- •Have a history of drug, excluding nicotine or caffeine, or alcohol abuse within 2 years of entry into the study
- •Already taking opioids.
- •Abnormal physical examination.
- •Inability to speak or read English
- •Patient declines participation.
研究组 & 干预措施
Open-label Placebo (COLP)
Placebo will be supplied as a 330mg tablet (manufactured by Consolidated Midland Corporation). Each oral opioid dose is a 5mg Oxycodone tablet. Patients will take placebo with each oral opioid intake and 3 additional times per day beginning on POD 1. Investigator shall never prescribe ibuprofen. Investigator shall always prescribe Tylenol 625mg every 8hrs (PRN).
干预措施: open-label placebo (Other)
Open-label Placebo (COLP)
Placebo will be supplied as a 330mg tablet (manufactured by Consolidated Midland Corporation). Each oral opioid dose is a 5mg Oxycodone tablet. Patients will take placebo with each oral opioid intake and 3 additional times per day beginning on POD 1. Investigator shall never prescribe ibuprofen. Investigator shall always prescribe Tylenol 625mg every 8hrs (PRN).
干预措施: Treatment as usual (Other)
Treatment As Usual (TAU)
Treatment As Usual (TAU) subjects will receive equal access to opioid and non-opioid analgesics. The preferred oral opioid dose is a 5mg Oxycodone pill. Subjects will take a placebo with each oral opioid dose and additional three times per day beginning on POD 1.
干预措施: Treatment as usual (Other)
结局指标
主要结局
The total amount of opioids consumed in oral morphine equivalents (OMEs) following surgery
时间窗: from admission to 6 weeks post-operatively
Oral morphine equivalents (OMEs) are values that represent the potency of an opioid dose relative to morphine. Using OMEs provides a standardized method for converting between various opiate medications. Each oral opioid dose is a 5mg Oxycodone tablet prescribed 6 times per day pro re nata. Participants will record the number of oral opioids taken each day for 6 weeks following surgery beginning on Post-op Day 1 (POD1). This data will be collected and converted into OMEs for comparison.
次要结局
- Weekly level of depressive symptoms and change from baseline in depressive symptoms on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Depressive Symptoms Short Form 8a at week 6.(weekly from admission to 6 weeks post-operatively)
- The duration of time in days following surgery until patients establish Independence with Physical Therapy(from admission to final physical therapy assessment, up to 6 weeks)
- Weekly level of mobility and change from baseline in mobility on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Pediatric Mobility Short Form 7a at week 6.(weekly from admission to 6 weeks post-operatively)
- Weekly level of anxiety and change from baseline in anxiety levels on the Patient-Reported Outcome Measurement Information System (PROMIS) Numeric Rating Scale Anxiety Short Form 8a at week 6.(weekly from admission to 6 weeks post-operatively)
- Whether participants experience urinary retention following surgery.(during hospitalization until discharge, up to 6 weeks)
- Whether participants experience constipation measured by the number of days between surgery and first bowel movement(from admission to date of first bowel movement, up to 6 weeks post-operatively)
- Whether participants experience an oxygen requirement and the duration of the requirement following surgery.(during hospitalization until discharge, up to 6 weeks)
- The length of time in days following surgery until discharge from the hospital(from admission to discharge, up to 6 weeks)
- The length of time in days following surgery until participant returns to school(from admission to date of return to school, up to 6 weeks post-operatively)