Comparison of Drugs on Headache Treatment After ECT Treatment

Mental Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03830398
• Other study ID #: 2018/171
• Status: Recruiting
• Phase: Phase 4
• Start date: November 20, 2018
• Est. completion date: June 2019

Study information

• Verified date: February 2019
• Source: Mustafa Kemal University
• Contact: Cagla Buket Akkurt, Prof
• Phone: +905053783204
• Email: caglabuket[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: June 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Headache
• Mental Disorders
• Psychotic Disorders

Intervention

Drug:
• Paracetamol
The investigators apply paracetamol during a week in preoperative room 45 min before ECT
• Deksketoprofen trometamol
The investigators apply paracetamol during a week in preoperative room 45 min before ECT
• Placebo
The investigators apply placebo during a week in preoperative room 45 min before ECT

Locations

Country	Name	City	State
Turkey	Mustafa Kemal University Medicine Faculty Anesthesiology Department	Hatay

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Isuru A, Rodrigo A, Wijesinghe C, Ediriweera D, Premadasa S, Wijesekara C, Kuruppuarachchi L. A randomized, double-blind, placebo-controlled trial on the role of preemptive analgesia with acetaminophen [paracetamol] in reducing headache following electroc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache (Visual Analogue Scale 0-10)	Headache (VAS) change is being assessed in three different time frames after ECT	Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
Secondary	Additive analgesic-antiemetic consumption	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.	Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
Secondary	Adverse effects (Nausea-Vomiting, bradycardia, hypotension)	Number of adverse efffects will be recorded in each interval.	Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)