IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Depression, Myalgia

In brief

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.

Key facts

Study ID

NCT01200069

Run by

Rutgers, The State University of New Jersey

People needed

14

Starts

2010-07-01

Expected to finish

2014-09-01

Last updated by the study team

2017-03-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University Hospital — Newark, New Jersey, United States

Full record on ClinicalTrials.gov

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