Comparison of Drugs on Headache Treatment After ECT Treatment

Phase 4

• Conditions: Mental Disorders
• Interventions: Drug: Placebo; Drug: Deksketoprofen trometamol; Drug: Paracetamol

• Registration Number: NCT03830398
• Lead Sponsor: Mustafa Kemal University

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.

Study Timeline

• Study Start: 2018-11-20
• Study First Submitted: 2019-01-15
• Status Verified: 2019-02
• Study First Submitted QC: 2019-02-02
• Last Update Submitted: 2019-02-02
• Study First Posted: 2019-02-05
• Last Update Posted: 2019-02-05
• Primary Completion: 2019-05
• Study Completion: 2019-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 225

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Placebo	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
Deksketoprofen trometamol	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
Paracetamol	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

Primary Outcome Measures

Name	Time	Method
Headache (Visual Analogue Scale 0-10)	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 Outcome Measures

Name	Time	Method
Additive analgesic-antiemetic consumption	Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)	If VAS ≥ 4, then diclofenac sodium im is given- If nausea-vomiting occurs, ondansetrone 4mg iv is given.The numbers of given drugs will be recorded in each interval.
Adverse effects (Nausea-Vomiting, bradycardia, hypotension)	Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)	Number of adverse efffects will be recorded in each interval.

Trial Locations

Locations (1)

Mustafa Kemal University Medicine Faculty Anesthesiology Department; 🇹🇷 Hatay, Turkey