Depression, Myalgia | IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia
Depression, Myalgia research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - 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. Exclusion Criteria: - 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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Placebo infusionIdentically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3
Drug:ibuprofen intravenousIV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Sugar water500 milliliters of intravenous ringers lactate administered over 30 minutes prior to ECT for treatments 1,2 and 3
Ibuprofen300mg/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
Start Date: July 2010
Completed Date: September 2014
Phase: Phase 4
Primary Outcome: Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1
Secondary Outcome: Subject Self Reported Numerical Rating of Incidence and Severity of Post Electroconvulsive Therapy Headache After Treatment Day 1
Study sponsors, principal investigator, and references
Principal Investigator: Vasanti Tilak, MD
Lead Sponsor: Rutgers, The State University of New Jersey