Clinical trial NCT03783312: Effects of Preemptive Paracetamol and Ibuprofen on Headache and Myalgia in Patients After Electroconvulsive Therapy
Official title: Effects of Preemptive Intravenous Paracetamol and Ibuprofen on Headache and Myalgia in Patients After Electroconvulsive Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Myalgia
Headache
Keywords: Electroconvulsive therapy
Intravenous paracetamol
Intravenous ibuprofen
Postoperative pain
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2018-12-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, Randomized, Placebo-Controlled Clinical Trial
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients with major depression
* Patients with American Society of Anesthesiologists (ASA) scores I or II
* Between 18-65

Exclusion Criteria:

* Patients with ASA scores III/IV,
* Under the age of 18,
* Over the age of 65,
* Myocardial infarction,
* Congestive heart failure,
* Pulmonary disease,
* Stroke history,
* Bleeding disorder,
* Hepatic and renal dysfunction,
* Pregnant,
* Migraine history,
* Allergy of nonsteroidal anti-inflammatory drugs, paracetamol, propofol,
* Neuromuscular disease,
* Peptic ulcer disease,
* Intracranial hypertension,
* Glaucoma
* Patients who did not give informed consent

Primary outcomes:
measure: Postoperative pain scores
timeFrame: From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Erol Karaaslan
state: Türkiye-Türkçe
Study officials:
affiliation: Inonu University Medical Faculty
name: Erol Karaaslan, Asst Prof
role: STUDY_DIRECTOR
References:
citation: Dinwiddie SH, Huo D, Gottlieb O. The course of myalgia and headache after electroconvulsive therapy. J ECT. 2010 Jun;26(2):116-20. doi: 10.1097/YCT.0b013e3181b07c0a.