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Comparison of Drugs on Headache Treatment After ECT Treatment

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ClinicalTrials.gov Identifier: NCT03830398
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Onur Koyuncu, 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.

Condition or disease Intervention/treatment Phase
Mental Disorders Drug: Paracetamol Drug: Deksketoprofen trometamol Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Each drug for one week
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Paracetamol and Dexketoprofen Trometamol on Headache Treatment After Electroconvulsive Treatment
Actual Study Start Date : November 20, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache

Arm Intervention/treatment
Active Comparator: 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
Drug: Paracetamol
The investigators apply paracetamol during a week in preoperative room 45 min before ECT
Other Name: Parol

Active Comparator: 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
Drug: Deksketoprofen trometamol
The investigators apply paracetamol during a week in preoperative room 45 min before ECT
Other Name: Sertofen

Placebo Comparator: 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
Drug: Placebo
The investigators apply placebo during a week in preoperative room 45 min before ECT
Other Name: Serum Physiologic




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Additive analgesic-antiemetic consumption [ Time Frame: 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.

  2. Adverse effects (Nausea-Vomiting, bradycardia, hypotension) [ Time Frame: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention) ]
    Number of adverse efffects will be recorded in each interval.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830398


Contacts
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Contact: Cagla Buket Akkurt, Prof +905053783204 caglabuket@gmail.com

Locations
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Turkey
Mustafa Kemal University Medicine Faculty Anesthesiology Department Recruiting
Hatay, Turkey, 31000
Contact: Onur Koyuncu, Assist. Prof    5337744757    onurko@yahoo.com   
Principal Investigator: Onur Koyuncu, Assoc.Prof         
Sub-Investigator: Sedat Hakimoglu, Assoc.Prof         
Sub-Investigator: Senem Urfali, Ast.Prof         
Sub-Investigator: Sumeyra Yesil, M.D.         
Sponsors and Collaborators
Mustafa Kemal University
Investigators
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Principal Investigator: Onur Koyuncu, Asc.Prof Mustafa Kemal Univ.
Study Chair: Sedat Hakimoglu, Asc.Prof Mustafa Kemal Univ.
Study Director: Senem Urfalı, Ast.Prof Mustafa Kemal Univ.
Principal Investigator: Sumeyra Yesil, Resident Mustafa Kemal Univ.

Publications of Results:
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Responsible Party: Onur Koyuncu, Assoc.Prof.MD, Mustafa Kemal University
ClinicalTrials.gov Identifier: NCT03830398     History of Changes
Other Study ID Numbers: 2018/171
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Headache
Mental Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics