Status:
TERMINATED
IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia
Lead Sponsor:
Rutgers, The State University of New Jersey
Conditions:
Depression, Myalgia
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
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 c...
Detailed Description
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 opioi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01200069
Start Date
July 1 2010
End Date
September 1 2014
Last Update
March 29 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital
Newark, New Jersey, United States, 07101