Effects of Preemptive Paracetamol and Ibuprofen on Headache and Myalgia in Patients After Electroconvulsive Therapy
Condition: Postoperative Pain; Myalgia; Headache
MeSH terms: Myalgia; Pain, Postoperative; Headache
Study type: Interventional

Summary: 
      The primary aim this prospective, randomized, double-blind, placebo-controlled clinical trial
      is to compare the analgesic effects of preemptive intravenous paracetamol and ibuprofen on
      headache and myalgia, and secondary aim is to evaluate the effects on hemodynamics, duration
      of seizure and postoperative side effects in patients who underwent electroconvulsive therapy
      .
    

Detailed description: 
      Electroconvulsive therapy (ECT) is one of the effective and life-saving treatment modality
      used in psychiatry for a long time because it responds more rapidly than pharmacological
      treatment. ECT is used safely in treatment-resistant depression, and in psychiatric disorders
      such as mania, schizoaffective disorder, schizophrenia, catatonia, and neuroleptic malignant
      syndrome. Treatment response to ECT in patients with severe depression and mania was reported
      as 83% and 78%, respectively.

      The electrical stimulation applied to the brain in ECT stimulates neuronal cells and a
      generalized tonic clonic seizure usually occurs for 20 to 60 seconds. ECT is performed 3
      times a week for a total of 6-12 sessions.

      The exact mechanism of ECT is not known, but (1) release of neurotransmitters such as
      dopamine, serotonin and norepinephrine (2) hypothalamic release of hormones such as prolactin
      and endorphins (3) gamma-aminobutyric acid conduction (4) increase in neurotrophic signaling
      and neurogenesis induction, and (5) factors such as changing the connection between different
      parts of the brain are thought to play a role.

      Although studies have shown the effectiveness of ECT in treatment, low mortality and
      morbidity rates, and several side effects have been reported. These; oral cavity damage to
      tongue, teeth, implants or intraosseous denture supports; confusion; dizziness; nausea and
      vomiting; headache, and myalgia.

      The etiology of headache after ECT is not fully understood; however, studies suggest that
      rapid contraction of the temporalis and masseter muscles due to ECT, vascular changes and
      serotonergic neurotransmission trigger headache. Headaches have been reported to be mild,
      moderate or severe and, in some cases, resistant to treatment.

      One of the most common side effects of ECT is myalgia. In some cases it is quite severe. The
      mechanism of myalgia is not fully known. Muscle contractions and muscle fasciculation due to
      succinylcholine use are thought to be effective in the formation of myalgia during the
      seizure induced by ECT. There are also studies showing that the using of succinylcholine is
      effective on the severity of myalgia.

      In cases with myalgia and headache are severe and untreated, patients cannot tolerate the
      pain. This may lead to discontinuation of treatment. Effective analgesic treatment is
      important for continued treatment and patient comfort.

      Painful stimuli from damaged tissue causes sensitization in peripheral and central pain
      pathways. Preemptive analgesia is a treatment that was initiated before the surgical
      procedure to reduce this sensitization and to inhibit the response to nociceptive stimuli.
      Preemptive analgesia has been described as an effective method to prevent headache after ECT.

      The primary aim this prospective, randomized, double-blind, placebo-controlled clinical trial
      is to compare the analgesic effects of preemptive intravenous paracetamol and ibuprofen on
      headache and myalgia, and secondary aim is to evaluate the effects on hemodynamics, duration
      of seizure and postoperative side effects in patients who underwent ECT.
    

Intervention name(s): placebo; paracetamol; ibuprofen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 250 ml saline will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. All administrations will be applied through IV infusion over 60 minutes.; 1 g paracetamol will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. All administrations will be applied through IV infusion over 60 minutes.; 800 mg ibuprofen will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. All administrations will be applied through IV infusion over 60 minutes.
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Randomized, Placebo-Controlled Clinical Trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Electroconvulsive therapy; Intravenous paracetamol; Intravenous ibuprofen; Postoperative pain