The Post-Operative Pain Management of Pediatric Supracondylar Elbow Fractures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- The Faces Pain Scale-Revised (FSP-R) Scores (Scored 0-10).
研究概览
简要总结
The goal of this study is to compare different ways of treating pain after surgery. This research study involves subjects who have a supracondylar elbow fracture and need surgery. This type of fracture occurs when the humerus (upper arm bone) is broken just above the elbow. Like any other surgery, you can expect that you will feel pain in the hours or days after the operation. Currently, despite the common occurrence of this surgery, there is not a standard way to treat and or prevent any of the pain afterwards.
At this hospital, oral (take by mouth) pain medicine is commonly used to treat pain after this surgery.
In this study, pain will be treated in one of the following ways:
- with oral pain medication
- with oral pain medicine and an intraarticular shot (a shot into the elbow joint) of bupivacaine (a "numbing" drug) or
- with oral pain medicine and an intraarticular shot of ropivacaine (another "numbing" drug). The shots will be given during surgery. Your participation will help us find out which of these three pain control methods works the best.
The correct dosages of all drugs will be safely prescribed by the doctor on an individual basis and all drugs will be used under the careful watch of your attending physician. All the drugs used this study are approved by the FDA for use in adults but they are not specifically approved for use in children. However, nearly 7 out of every 10 drugs approved for adults are not specifically approved by the FDA for use in children. All drugs used in this study will be used in a way that is considered to be safe and reasonable by the Children's Hospital.
详细描述
Purpose: In recent years, despite the lack of consistent evidence, the use of intraarticular (into the joint)injections during ambulatory, orthopaedic surgery has become a popular strategy for reducing post-operative pain. In this randomized, single center, prospective study the investigators will evaluate the analgesic effectiveness of intraarticular injections of local anesthesia during the closed reduction and percutaneous pinning (CRPP) of supracondylar type elbow fractures (SCEFx) in children. In order to determine the efficacy of intraarticular injections, perceived post-operative pain will be compared among the three study groups receiving either a 0.25 % intraarticular injection of bupivacaine (Group 1 ), a 0.20% intraarticular injection of ropivacaine (Group 2) or no intraarticular injection (Control). All groups will receive the same post-operative oral pain medication of oxycodone (0.1 to 0.15 mg/kg) with acetaminophen.
Primary Aim(s) : Compare the primary and secondary pain outcomes variables in each of the three study groups.
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The primary pain outcome variables are defined as the following:
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Self-reported pain within 30-60 min. of arrival to the recovery room
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Self-reported pain at two hours post-operative
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The secondary pain outcome variables are defined as the following:
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Parent perception of post-operative pain (scores of modified version of Foster and Varni's Total Quality of Pain Management Survey (TQPM) given in the first two hours after surgery)
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Time t o first administration of oral pain medication
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Total dose and frequency of oral pain medication taken during first 72 hours post-operative
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Dose (per kg) of local anesthetic received intra-operatively
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Total dosage of all intra-operative analgesics (in morphine equivalents)
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Pre-operative The Faces Pain Scale-Revised (FSP-R) score
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
- Single (Participant)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA class I, II or III
- •Patients 4-12 years old requiring general anesthesia for closed reduction and percutaneous pinning (CRPP) of supracondylar type elbow fractures (SCEFx).
- •Patients able to understand and report their pain with the Faces Pain Scale Revised
排除标准
- •Medical contraindications to analgesic therapy.
- •Known allergy or sensitivity to analgesic agent.
- •Clinical evidence of skin inflammation precluding the 'clean' area at the site of injection.
- •Patients lacking the cognitive understanding to report their pain with the FSP-R (unable to complete seriation task).
- •Patients necessitating open reduction due to inability to obtain an acceptable closed reduction.
- •Comorbid diagnosis of other traumatic injury that causes any local and or global pain.
- •Patients presenting to ER with neurovascular injury or compartment syndrome due to fracture.
- •For patients in either of the two intervention arms, if after three attempts, the intraarticular injection is not successful, the patient will be dropped from the study.
- •Patients admitted for complications directly related to the surgery will be dropped from analysis. Any such event will be immediately reported to COMIRB with in five business days. However, patients admitted due to a late afternoon/evening surgery and patients admitted for standard observational purposes unrelated to surgical complications, will not be dropped from the study.
- •Known drug allergy to oxycodone and or acetaminophen.
- •Children 4-7 years old weighing less than 14 kg (Weight exclusion criteria is based on a 4 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).
- •Children 8-12 years old weighing less than 20 kg (Weight exclusion criteria based on an 8 year old female that is below the fifth percentile for weight, per the Center for Disease Control Growth Charts).
研究组 & 干预措施
The group receiving oral pain medicine
This group will receive Oxycodone with Acetaminophen orally
干预措施: Oxycodone with Acetaminophen (Drug)
The group receiving bupivacaine and oral pain medicine
This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
干预措施: Bupivacaine 0.25% (Drug)
The group receiving ropivacaine and oral pain medicine
This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
干预措施: Ropivacaine 0.20% (Drug)
结局指标
主要结局
The Faces Pain Scale-Revised (FSP-R) Scores (Scored 0-10).
时间窗: Will be obtained 30 - 60 minutes after arrival to the recovery room
The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain.
次要结局
- Total Quality Pain Management Survey (TQPM) Scores for Questions # 16: Child's Current Level of Pain, Question # 17: Child's Worst Level of Pain When Moving Around After Surgery and Question # 18: Child's Worst Level of Pain While Resting(Will be obtained from parent(s) 120 minutes after arrival to the recovery room)
- Time (in Minutes) to First Narcotic Administration(first 72 hours after surgery close time)
- Total Dosage in Morphine Equivalents (mg/kg) of All Analgesics Received in Prior to Discharge(Analgesic data collected during first four hours following the end of surgery (surgery close))
- Need for IV Morphine of Fentanyl(First 120 minutes after the end of surgery (surgery close time))