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

Primary Purpose

Postoperative Pain, Myalgia, Headache

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
placebo
paracetamol
ibuprofen
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Electroconvulsive therapy, Intravenous paracetamol, Intravenous ibuprofen, Postoperative pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erol Karaaslan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

placebo

paracetamol

ibuprofen

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Postoperative pain scores
Visual Analog Scale (Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.It is often used in epidemiologic and clinical research to measure the intensity or frequency of various pain. minimum: 0, maximum: 10, 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-10: severe pain)

Secondary Outcome Measures

Full Information

First Posted
December 14, 2018
Last Updated
April 2, 2019
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT03783312
Brief Title
Effects of Preemptive Paracetamol and Ibuprofen on Headache and Myalgia in Patients After Electroconvulsive Therapy
Acronym
ECT
Official Title
Effects of Preemptive Intravenous Paracetamol and Ibuprofen on Headache and Myalgia in Patients After Electroconvulsive Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
February 7, 2019 (Actual)
Study Completion Date
February 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Myalgia, Headache
Keywords
Electroconvulsive therapy, Intravenous paracetamol, Intravenous ibuprofen, Postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, Randomized, Placebo-Controlled Clinical Trial
Masking
Participant
Masking Description
Single (Participant)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
paracetamol
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ibuprofen
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
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
Intervention Name(s)
paracetamol
Intervention Description
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
Intervention Name(s)
ibuprofen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative pain scores
Description
Visual Analog Scale (Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.It is often used in epidemiologic and clinical research to measure the intensity or frequency of various pain. minimum: 0, maximum: 10, 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-10: severe pain)
Time Frame
From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erol Karaaslan, Asst Prof
Organizational Affiliation
Inonu University Medical Faculty
Official's Role
Study Director
Facility Information:
Facility Name
Erol Karaaslan
City
Malatya
State/Province
Türkiye-Türkçe
ZIP/Postal Code
44090
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19710619
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.
Results Reference
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Effects of Preemptive Paracetamol and Ibuprofen on Headache and Myalgia in Patients After Electroconvulsive Therapy

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