IV Ibuprofen for Post-Electroconvulsive Therapy Myalgia
Condition: Depression, Myalgia
MeSH terms: Myalgia; Depression
Intervention: Placebo infusion; ibuprofen intravenous
Intervention description: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3; IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3
Intervention MeSH terms: Ibuprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: depression,myalgia

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.
    

Eligibility 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