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Clinical Trials/NCT03830398
NCT03830398
Unknown
Phase 4

Comparison of Paracetamol and Dexketoprofen Trometamol on Headache Treatment After Electroconvulsive Treatment

Mustafa Kemal University1 site in 1 country225 target enrollmentNovember 20, 2018

Overview

Phase
Phase 4
Intervention
Paracetamol
Conditions
Mental Disorders
Sponsor
Mustafa Kemal University
Enrollment
225
Locations
1
Primary Endpoint
Headache (Visual Analogue Scale 0-10)
Last Updated
7 years ago

Overview

Brief Summary

Electroconvulsive treatment (ECT) is still actual for treatment of psychiatric symptoms. Headache is a very common symptom after this application. The investigators compare the effect of two different drugs for the treatment of headache after ECT.

Detailed Description

Electroconvulsive treatment (ECT) is used as an alternative application instead of drug therapy for psychiatric symptoms. ECT application is repeated 8-12 times according to the treatment of the patient. This treatment is done in 2 or 3 days intervals. The most adverse effects of ECT are headache, memory disorders, myalgia, nausea and vomiting, cardiovascular problems. The most common seen adverse effect is headache with approximately 60% incidence. The main drugs used for the treatment of headache related to ECT are NSAIs and paracetamol. The aim of the current study is to compare the effect of paracetamol and dexketoprofen trometamol on headache treatment after ECT.

Registry
clinicaltrials.gov
Start Date
November 20, 2018
End Date
June 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Onur Koyuncu

Assoc.Prof.MD

Mustafa Kemal University

Eligibility Criteria

Inclusion Criteria

  • All patients who were admitted for ECT and gave informed written consent were included in the study.

Exclusion Criteria

  • Exclusion criteria included patients who gave a history of allergy to acetaminophen, lacked capacity to give informed consent and developed complications such as delirium following ECT.

Arms & Interventions

Paracetamol

Parol group: intravenous infusion in 30 min Generic name: Parol Dosage form: intravenous Dosage: 1 gr Frequency: preop one dose only Duration: For one week

Intervention: Paracetamol

Deksketoprofen trometamol

Sertofen group: intravenous infusion in 30 min Generic name: Sertofen Dosage form: intravenous Dosage: 50 mg Frequency: preop one dose only Duration: For one week

Intervention: Deksketoprofen trometamol

Placebo

Placebo group: intravenous infusion in 30 min Generic name: Serum physiologic Dosage form: intravenous Dosage: 100 ml Frequency: preop one dose only Duration: For one week

Intervention: Placebo

Outcomes

Primary Outcomes

Headache (Visual Analogue Scale 0-10)

Time Frame: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)

Headache (VAS) change is being assessed in three different time frames after ECT

Secondary Outcomes

  • Additive analgesic-antiemetic consumption(Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention))
  • Adverse effects (Nausea-Vomiting, bradycardia, hypotension)(Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention))

Study Sites (1)

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