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IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia

This study has been terminated.
(unable to increase to target enrollment)
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT01200069
First received: August 19, 2010
Last updated: September 27, 2016
Last verified: March 2015
  Purpose
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.

Condition Intervention Phase
Depression, Myalgia
Drug: Placebo infusion
Drug: ibuprofen intravenous
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Intravenous Ibuprofen/Caldolor 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 IV Ibuprofen Will Attenuate & Decrease the Severity of Post ECT Myalgia [ Time Frame: Treatment day 1 at 1hour, 6 hour, 24 hours, 48 hours ] [ Designated as safety issue: No ]
    subject self reporting rating scale for severity of myalgias utilizing numeric rating scale 0= no pain, 1-3= mild pain, annoyance with little interference with Activities of Daily Living (ADL), 4-6= moderate (interferes significantly with ADL, 7-10 = severe pain unable to perform ADL

  • Myalgia Reported on Treatment Day 2 [ Time Frame: 1 hour, 6 hours, 24 hours & 48 hours following procedure ] [ Designated as safety issue: No ]
    Subject self reported numerical rating of incidence and severity of post ECT Myalgia after treatment day 2 0=no pain, 1-3=mild pain (annoying, little interference with ADL), 4-6= moderate,( interferes significantly with ADL) 7-10 severe pain (unable to perform everyday activities)

  • Myalgia Reported After Treatment #3 [ Time Frame: 1 hour, 6 hour, 24 hour, 48 hour after 3rd ECT treatment ] [ Designated as safety issue: No ]
    Subject self reported severity of myalgia based on a self reported assessment utilizing numeric rating scale 0=no myalgia, 1-3=mild myalgia (annoying, little interference with ADL);4-6=moderate (interferes significantly with ADL); 7-10 severe myalgia(unable to perform every day activities)


Secondary Outcome Measures:
  • Pre-treatment With IV Ibuprofen Will Attenuate and Decrease the Severity of Post ECT Headache at Treatment Day 1 [ Time Frame: 1 hour, 6 hours, 24 hours & 48 hours following procedure ] [ Designated as safety issue: No ]
    Subject self reported numerical rating of incidence and severity of Post ECT pain score for headache at 1, 6, 24 and 48 hours post procedure. Pain Rating 0= no pain, 2-4=moderate pain, 5-7=distressing severe pain, 8-9=intense very severe pain, 10=unbearable pain

  • Incidence and Severity of Headache After ECT Treatment 2 [ Time Frame: 1 hour, 6 hour, 24 hour and 48 hours ] [ Designated as safety issue: No ]
    Subject self reported numerical rating of incidence and severity of post ECT headache 0=no pain, 2-4=moderate pain, 5-7= distressing severe pain, 8-9= very severe pain, 10=unbearable pain.

  • Incidence of Headache & Severity Headache After ECT Treatment #3 [ Time Frame: 1 hour after treatment, 6 hours, 24 hours and 48 hours ] [ Designated as safety issue: No ]
    Subject self reported numerical rating of incidence and severity of post ECT headache after treatment #3, 0=no pain, 2-4=moderate pain, 5-7=distressing severe pain, 8-9 very serious pain, 10=unbearable pain.


Enrollment: 14
Study Start Date: July 2010
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar water
500 milliliters of intravenous ringers lactate administered over 30 minutes prior to ECT for treatments 1,2 and 3
Drug: Placebo infusion
Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3
Other Name: lactated ringers
Active Comparator: Ibuprofen
300mg/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
Drug: ibuprofen intravenous
IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3
Other Name: Caldolor

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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

Locations
United States, New Jersey
University Hospital
Newark, New Jersey, United States, 07101
Sponsors and Collaborators
Rutgers, The State University of New Jersey
Investigators
Principal Investigator: Vasanti Tilak, MD UMDNJ-NJMS
  More Information

Responsible Party: 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
Results First Received: February 24, 2016
Last Updated: September 27, 2016
Health Authority: United States: Food and Drug Administration
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Depression
Myalgia
Behavioral Symptoms
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 02, 2016