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

NCT03783312 | Completed

• 1 other identifier: ekaraaslan1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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 .

Conditions

Postoperative Pain; Myalgia; Headache

Keywords

Electroconvulsive therapy; Intravenous paracetamol; Intravenous ibuprofen; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• 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)

  From end of anesthesia (15 minutes after anesthesia) to after 24 hours, up to 24 hours

Study Arms (3)

placebo

PLACEBO COMPARATOR

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.

Drug: placebo

paracetamol

ACTIVE COMPARATOR

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.

Drug: paracetamol

ibuprofen

ACTIVE COMPARATOR

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.

Drug: ibuprofen

Interventions

placebo 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.

placebo

paracetamol 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.

paracetamol

ibuprofen 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.

ibuprofen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Erol Karaaslan

Malatya, Türkiye-Türkçe, 44090, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 19710619 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Myalgia; Headache

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Erol Karaaslan, Asst Prof

  Inonu University Medical Faculty

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single (Participant)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof. Dr. Erol Karaaslan

Model Details: Prospective, Randomized, Placebo-Controlled Clinical Trial

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 21, 2018
• Study Start: December 20, 2018
• Primary Completion: February 7, 2019
• Study Completion: February 10, 2019
• Last Updated: April 3, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)