Effects of Preemptive Paracetamol and Ibuprofen on Headache and Myalgia in Patients After Electroconvulsive Therapy

NCT ID: NCT03783312

Last Updated: 2019-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-20
• Study Completion Date: 2019-02-10

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.

Conditions

Postoperative Pain; Myalgia; Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

placebo

250 ml saline will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. 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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

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.

paracetamol

1 g paracetamol will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. 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.

Group Type: ACTIVE_COMPARATOR

paracetamol

Intervention Type: DRUG

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.

ibuprofen

800 mg ibuprofen will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. 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.

Group Type: ACTIVE_COMPARATOR

ibuprofen

Intervention Type: DRUG

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.

Interventions

placebo

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.

Intervention Type: DRUG

paracetamol

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.

Intervention Type: DRUG

ibuprofen

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 Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Erol Karaaslan

Asst. Prof. Dr. Erol Karaaslan

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Erol Karaaslan, Asst Prof

Role: STUDY_DIRECTOR

Inonu University Medical Faculty

Locations

Erol Karaaslan

Malatya, Türkiye-Türkçe, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 19710619 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ekaraaslan1

Identifier Type: -

Identifier Source: org_study_id