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临床试验/NCT04950660
NCT04950660已完成4 期

Oral Caffeine Decreases the Frequency of Opioid Demand in AIS Patients After Spinal Fusion

Children's Mercy Hospital Kansas City1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2019年12月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
61
试验地点
1
主要终点
Total Post Operative Oral Morphine Milligram Equivalents (MME)/Kilogram (Kg) for Hospital Stay

研究概览

简要总结

Prospective, randomized control trial To determine if oral caffeine decreases the frequency of opioid demand in children with adolescent idiopathic scoliosis after their spinal fusion surgery To compare pain scale ratings, number of requests for diazepam, average heart rate, average blood pressure, sex, age, ethnicity, post-op day of discharge, operative time, estimated intraoperative blood loss, remittance post-surgery, length of hospital stay, and segments fused during spinal fusion surgery.

详细描述

Because these receptors are so important for modifying pain and inflammation, caffeine has been added as an adjuvant to common analgesics, such as paracetamol, ibuprofen, and aspirin in the belief that it will enhance their analgesic efficacy. Most studies used paracetamol or ibuprofen with 100 mg to 130 mg caffeine, and the most common pain conditions studied were postoperative dental pain, postpartum pain, and headache. There was a small but statistically significant benefit with caffeine used at doses of 100 mg or more, which was not dependent on the pain condition or type of analgesic. Additionally, trials have shown superior efficacy of adding caffeine to ibuprofen instead of administering ibuprofen alone for treating acute pain, reflecting that caffeine is an effective analgesic adjuvant. The addition of caffeine (≥ 100 mg) to a standard dose of commonly used analgesics provides a small but important increase in the proportion of participants who experience a good level of pain relief.

Finally, the beneficial effects of caffeine on aerobic activity and resistance training performance are well documented. Studies have shown that caffeine ingestion resulted in significantly lower levels of soreness compared with placebo (p ≤ 0.05). A further beneficial effect of sustained caffeine ingestion in the days after the exercise bout is an attenuation of delayed onset muscle soreness. Orthopaedic surgery also causes muscle injury, and patients might benefit from caffeine's effect on lowering muscle soreness. Acute caffeine administration also has been shown to demonstrate increases in alertness, contentment, motivation to work, talkativeness, and energy. It also decreases muscle twitches. All of these effects would be beneficial in the post-operative period, especially for Adolescence Idiopathic Scoliosis (AIS) patients undergoing spinal fusion surgery in the orthopaedic department at Children's Mercy Hospital.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

This study will be a prospective, randomized control trial and will be double-blinded, with the patient, provider, and researcher blinded to the treatment.

入排标准

年龄范围
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • must meet criteria for surgical correction of scoliosis
  • must be able to swallow pills
  • must have English as a primary language
  • must possess mental capacity to understand purpose of the study
  • patient must carry diagnosis of adolescent idiopathic scoliosis
  • surgery must be performed via posterior approach
  • operation performed by either Dr. John T. Anderson, Dr. Richard M. Schwend, Dr. Aaron Shaw, Dr. Michael Benvenuti
  • post-surgical AIS patients from June 2019-June 2024
  • the patient must be between the ages of 12 and 17 years old
  • the patient and one of their biological parents or guardian(s) must give consent for patient to be included in this study
  • Negative Suicide screen

排除标准

  • obesity, as defined by a BMI at or above the 95th percentile
  • weight below 40 kg
  • any orthopedic diagnosis other than AIS
  • revision spine surgery
  • anterior or combined approach
  • admission to PICU post-op
  • use of Oxycodone post-op
  • allergies to ibuprofen, caffeine, codeine, or diazepam
  • history of renal disease
  • history of a coagulation disorder
  • history of cardiac dysrhythmia or open heart surgery
  • history of Chronic Pain Syndrome or Complex Regional Pain Syndrome
  • current use of oral central nervous system stimulant (e.g. methylphenidate)
  • Positive Suicide screen
  • The following populations will be excluded:
  • Children over the age of 18, or turning 18 during time of surgical treatment
  • Children or parents unable to consent
  • Individuals with cognitive delays
  • Pregnant females
  • Prisoners
  • Wards of the state

研究组 & 干预措施

Caffeine arm

Active Comparator

Experimental Group: patient group (n = 34) receiving a 100 mg dose of caffeine (1/2 of a 200mg tablet to be taken whole or crushed), taken twice daily. This will be an adjuvant to their standard pain control.

干预措施: Caffeine Tablet (Drug)

Placebo arm

Placebo Comparator

Control group: patient group (n = 34) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.

干预措施: Caffeine Tablet (Drug)

Placebo arm

Placebo Comparator

Control group: patient group (n = 34) receiving placebo compounded to look similar to the caffeine treatment, taken twice daily. This will be an adjuvant to their standard pain control.

干预措施: Placebo (Drug)

结局指标

主要结局

Total Post Operative Oral Morphine Milligram Equivalents (MME)/Kilogram (Kg) for Hospital Stay

时间窗: For hospital stay up to 7 days

Total Post Operative Oral Morphine milligram equivalents (MME)/kilogram (Kg) for Hospital Stay

次要结局

  • Mean Daily Verbal Analog Scale (VAS)(For hospital stay up to 7 days)
  • Average Heart Rate During Hospital Stay(For hospital stay up to 7 days)
  • Average Systolic Blood Pressure During Hospital Stay(For hospital stay up to 7 days)

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anne Stuedemann

APRN III

Children's Mercy Hospital Kansas City

研究点 (1)

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