IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Rutgers, The State University of New Jersey
Sponsor:
Information provided by (Responsible Party):
Anesthesia, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01200069
First received: August 19, 2010
Last updated: June 11, 2014
Last verified: June 2014
  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 Rutgers, The State University of 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: May 2015
Estimated Primary Completion Date: December 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01200069

Contacts
Contact: Vasanti Tilak, MD 973 972-5254 tilakva@njms.rutgers.edu
Contact: Catherine E Schoenberg, BSN 973 972-7477 shoenbce@njms.rutgers.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
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Vasanti Tilak, MD UMDNJ-NJMS
  More Information

No publications provided

Responsible Party: Anesthesia, Director of General Anesthesiology, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT01200069     History of Changes
Other Study ID Numbers: 0120100189
Study First Received: August 19, 2010
Last Updated: June 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Myalgia
Behavioral Symptoms
Mood Disorders
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
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 August 21, 2014