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临床试验/NCT01200069
NCT01200069终止4 期

Intravenous Ibuprofen/Caldolor for Post-Electroconvulsive Therapy Myalgia

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2010年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
14
试验地点
1
主要终点
Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1

研究概览

简要总结

Post-procedure myalgia (muscle ache) is a well-known and common complication of Electro-convulsive Treatment (ECT). Myalgias are a serious concern of patients and occur in approximately 50% of these cases. The pain is usually described as muscle soreness, similar to that resulting from strenuous exercise. The myalgias typically begin shortly after the procedure, lasting approximately 2-7 days in total. A recent study reported that 89% of patients considered prevention significant and would be willing to pay a median of $33 out of pocket to avoid this side effect. In addition to patient discomfort, myalgias can have a further financial burden if these patients are unable to return to work or resume previous daily activities in the days following the procedure. An agent that could treat and possibly even prevent these myalgias has the potential to be very beneficial to these patients. IV ibuprofen (trade name Caldolor) is a novel therapeutic modality approved by the US Food and Drug Administration (FDA) in June 2009 for the treatment of mild to moderate pain, as an adjunct to opioid analgesics, and for the reduction of fever.

详细描述

IV ibuprofen (trade name Caldolor) is a novel therapeutic modality approved by the US Food and Drug Administration (FDA) in June 2009 for the treatment of mild to moderate pain, as an adjunct to opioid analgesics, and for the reduction of fever. Ibuprofen is a non-steroidal anti-inflammatory drug (NSAID), which produces its effect through inhibition of the enzyme cyclooxygenase (COX). There are at least 2 variations of cyclooxygenase (COX-1 and COX-2) and ibuprofen non-selectively inhibits both, thus decreasing prostaglandin synthesis. This action gives ibuprofen its analgesic, anti-pyretic, and anti-inflammatory properties. NSAIDs have an established history of efficacy in the treatment of both acute and chronic somatic pain. Caldolor, being an intravenous formulation, offers a distinct advantage in patients who either are unable to take medications orally or are fasting preoperatively.

Post-procedure myalgia is a well-known and common complication of ECT. Although the exact etiology is unknown, the myalgias are believed to result from a combination of succinylcholine administration and the seizure activity induced by the ECT procedure itself. Succinylcholine-induced postoperative myalgias are a well-known phenomenon, initially described in the early 1950's. The exact pathogenesis is unknown, with muscle damage from succinylcholine-induced fasciculations or calcium-mediated phospholipase A2 activation and prostaglandin production being proposed as possible etiologies. The latter mechanism provides the rationale for using NSAID therapy. However, succinylcholine is unlikely to be the only factor involved in the development of myalgias following ECT, as a recent study showed that dose adjustments to succinylcholine did not affect rates of myalgia in these patients. Furthermore, seizures can also cause direct muscle injury and there have been reports of muscle pain after ECT both with and without succinylcholine.

A thorough literature search using Medline, Ovid, and scholar.google failed to find any research articles evaluating pretreatment therapy for myalgias in post-ECT patients. The current practice for the treatment of myalgias following ECT has been extrapolated from research on succinylcholine-induced myalgia in post-surgical patients. Previous studies have shown at least partial efficacy with pretreatment of nondepolarizing neuromuscular blocking agents, benzodiazepines, sodium channel blockers (predominantly lidocaine), and nonsteroidal anti-inflammatory drugs. The nature of the ECT procedure itself makes several of these modalities undesirable. Both Lidocaine and benzodiazepines can alter the seizure threshold and the short duration of the procedure possibly increases the risks associated with longer acting nondepolarizing muscle relaxants (ie. blurred vision, diplopia, difficulty breathing and swallowing). Therefore, the options for pretreatment are limited. In addition, a recent meta-analysis of randomized trials determined NSAIDs to cumulatively have the best efficacy of any pretreatment therapy in the prevention of post-procedural myalgias. Due to its intravenous formulation, some practitioners have administered ketorolac to ECT patients before the procedure. However, despite a proven efficacy in myalgia prevention shown by NSAIDs as a class, a study specifically examining the use of ketorolac in this regard failed to show any benefit. The use of Ibuprofen has yet to be examined.

Myalgias are a serious concern of patients and occur in approximately 50% of these cases. The pain is usually described as muscle soreness, similar to that resulting from strenuous exercise. The myalgias typically begin shortly after the procedure, lasting approximately 2-7 days in total. A recent study reported that 89% of patients considered prevention significant and would be willing to pay a median of $33 out of pocket to avoid this side effect. In addition to patient discomfort, myalgias can have a further financial burden if these patients are unable to return to work or resume previous daily activities in the days following the procedure. An agent that could treat and possibly even prevent these myalgias has the potential to be very beneficial to these patients.

Experimental Plan:

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Capable of providing informed consent
  • American Society Anesthesiologists (ASA) rating I-III
  • Subjects age 18-80 capable of providing consent.
  • Subjects undergoing electroconvulsive therapy using succinylcholine as the sole neuromuscular blocking agent.
  • Subjects who have scored ≥23 on the Mini-Mental State Examination.

排除标准

  • Subjects who have had a recent thrombotic event, myocardial infarction or stroke or episode of Congestive Heart Failure (CHF) within less than 3 months.
  • Subjects who have had a recent cardiovascular surgery within the last 3 months.
  • Subjects with active Gastrointestinal bleeding
  • Subjects who have asthma, itching or allergic type reaction following aspirin or other NSAID administration
  • Subjects with a known hypersensitivity to ibuprofen
  • Subjects with heart failure, bleeding disorders or kidney failure
  • Subjects taking aspirin, Angiotensin converting enzyme (ACE) inhibitors, or anticoagulants within one month.
  • Subjects with any devices used to treat pain (intrathecal pumps, spinal cord stimulators etc)
  • Subjects with a history of fibromyalgia or chronic myositis
  • Subjects who are pregnant
  • Subjects who do not have a phone
  • Subjects who have had previous ECT
  • Subjects receiving toradol (Ketorolac)
  • Subjects with reported renal disease within less than 3 months.
  • Subjects who have had previous electroconvulsive therapy within the last 3 months

研究组 & 干预措施

Sugar water

Placebo Comparator

500 milliliters of intravenous ringers lactate administered over 30 minutes prior to ECT for treatments 1,2 and 3

干预措施: Placebo infusion (Drug)

Ibuprofen

Active Comparator

300mg/8milliliters of intravenous ibuprofen/caldolor over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3

干预措施: ibuprofen intravenous (Drug)

结局指标

主要结局

Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1

时间窗: Treatment day 1 at 1hour, 6 hour, 24 hours, 48 hours

subject self reporting rating scale for severity of myalgias utilizing numeric rating scale 0= no pain, 1-3= mild pain, annoyance with little interference with Activities of Daily Living (ADL), 4-6= moderate (interferes significantly with ADL, 7-10 = severe pain unable to perform ADL

Myalgia Reported on Treatment Day 2

时间窗: 1 hour, 6 hours, 24 hours & 48 hours following procedure

Subject self reported numerical rating of incidence and severity of post ECT Myalgia after treatment day 2 0=no pain, 1-3=mild pain (annoying, little interference with ADL), 4-6= moderate,( interferes significantly with ADL) 7-10 severe pain (unable to perform everyday activities)

Myalgia Reported After Treatment #3

时间窗: 1 hour, 6 hour, 24 hour, 48 hour after 3rd ECT treatment

Subject self reported severity of myalgia based on a self reported assessment utilizing numeric rating scale 0=no myalgia, 1-3=mild myalgia (annoying, little interference with ADL);4-6=moderate (interferes significantly with ADL); 7-10 severe myalgia(unable to perform every day activities)

次要结局

  • Incidence and Severity of Headache After ECT Treatment 2(1 hour, 6 hour, 24 hour and 48 hours)
  • Incidence of Headache & Severity Headache After ECT Treatment #3(1 hour after treatment, 6 hours, 24 hours and 48 hours)
  • Subject Self Reported Numerical Rating of Incidence and Severity of Post Electroconvulsive Therapy Headache After Treatment Day 1(1 hour, 6 hours, 24 hours & 48 hours following procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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