IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia

NCT01200069 | Terminated Phase 4 Results

• 1 other identifier: 0120100189
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Depression, Myalgia

Keywords

depression,myalgia

Outcome Measures

Primary Outcomes (3)

• Subject Self Reported Numerical Rating of Incidence and Severity of Post-Electroconvulsive Therapy Myalgias After Treatment 1

  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

  Treatment day 1 at 1hour, 6 hour, 24 hours, 48 hours

• Myalgia Reported on Treatment Day 2

  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)

  1 hour, 6 hours, 24 hours & 48 hours following procedure

• Myalgia Reported After Treatment #3

  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)

  1 hour, 6 hour, 24 hour, 48 hour after 3rd ECT treatment

Secondary Outcomes (3)

• Subject Self Reported Numerical Rating of Incidence and Severity of Post Electroconvulsive Therapy Headache After Treatment Day 1

  1 hour, 6 hours, 24 hours & 48 hours following procedure

• Incidence and Severity of Headache After ECT Treatment 2

  1 hour, 6 hour, 24 hour and 48 hours

• Incidence of Headache & Severity Headache After ECT Treatment #3

  1 hour after treatment, 6 hours, 24 hours and 48 hours

Study Arms (2)

Sugar water

PLACEBO COMPARATOR

500 milliliters of intravenous ringers lactate administered over 30 minutes prior to ECT for treatments 1,2 and 3

Drug: Placebo infusion

Ibuprofen

ACTIVE COMPARATOR

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

Interventions

Placebo infusion DRUG

Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3

Also known as: lactated ringers

Sugar water

ibuprofen intravenous DRUG

IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3

Also known as: Caldolor

Ibuprofen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

University Hospital

Newark, New Jersey, 07101, United States

Location

MeSH Terms

Conditions

Depression; Myalgia

Interventions

Ringer's Lactate; Ibuprofen

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Vasanti Tilak, MD
• Organization: Rutgers/New Jersey Medical School

tilakva@njms.rutgers.edu

974 972-5254

Study Officials

• Vasanti Tilak, MD

  UMDNJ-NJMS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2010
• First Posted: September 13, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: March 29, 2017
• Results First Posted: November 18, 2016

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)