IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia
This study is currently recruiting participants.
Verified January 2013 by University of Medicine and Dentistry New Jersey
Sponsor:
University of Medicine and Dentistry New Jersey
Information provided by (Responsible Party):
Anesthesia, University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT01200069
First received: August 19, 2010
Last updated: January 18, 2013
Last verified: January 2013
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Purpose
Post-procedure myalgia (muscle ache) is a well-known and common complication of 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: Placebo infusion Drug: ibuprofen intravenous |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Intravenous Ibuprofen for Post-Electroconvulsive Therapy Myalgia |
Resource links provided by NLM:
Further study details as provided by University of Medicine and Dentistry New Jersey:
Primary Outcome Measures:
- Pre-treatment with intravenous ibuprofen will attenuate the incidence & severity of post ECT myalgias [ Time Frame: various intervals up to 48 hours ] [ Designated as safety issue: No ]pre ECT pain score baseline,and pain scores at 1, 6, 24 and 48 hours post procedure
Secondary Outcome Measures:
- Pre-treatment with IV ibuprofen will attenuate and decrease the severity of post ECT headache [ Time Frame: various intervals up to 48 hours post procedure ] [ Designated as safety issue: No ]Pre ECT pain score baseline followed by pain score at 1, 6, 24 and 48 hours post procedure
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Sugar water |
Drug: Placebo infusion
Identically appearing placebo dose administered IV
|
| Active Comparator: Ibuprofen |
Drug: ibuprofen intravenous
IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT
Other Name: Caldolor
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Capable of providing informed consent
- 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 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, 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200069
Contacts
| Contact: Vasanti Tilak, MD | 973 972-5254 | tilakva@umdnj.edu |
| Contact: Catherine E Schoenberg, BSN | 973 972-7477 | shoenbce@umdnj.edu |
Locations
| United States, New Jersey | |
| University Hospital | Recruiting |
| Newark, New Jersey, United States, 07101 | |
| Principal Investigator: Vasanti Tilak, MD | |
| Sub-Investigator: Ye-Ming J Sun, MD, PhD | |
| Sub-Investigator: Giovanni Caracci, MD | |
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Investigators
| Principal Investigator: | Vasanti Tilak, MD | UMDNJ-NJMS |
More Information
No publications provided
| Responsible Party: | Anesthesia, Director of General Anesthesiology, University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT01200069 History of Changes |
| Other Study ID Numbers: | 0120100189 |
| Study First Received: | August 19, 2010 |
| Last Updated: | January 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Medicine and Dentistry New Jersey:
|
depression |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Ibuprofen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013