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Comparison of Drugs on Headache Treatment After ECT Treatment

Primary Purpose

Mental Disorders

Status

Unknown status

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Paracetamol

Deksketoprofen trometamol

Placebo

About this trial

This is an interventional treatment trial for Mental Disorders

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mustafa Kemal University Medicine Faculty Anesthesiology DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Paracetamol

Deksketoprofen trometamol

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Headache (Visual Analogue Scale 0-10)

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

Secondary Outcome Measures

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.

Adverse effects (Nausea-Vomiting, bradycardia, hypotension)

Number of adverse efffects will be recorded in each interval.

Full Information

NCT ID

NCT03830398

First Posted

January 15, 2019

Last Updated

February 2, 2019

Sponsor

Mustafa Kemal University

1. Study Identification

Unique Protocol Identification Number

NCT03830398

Brief Title

Comparison of Drugs on Headache Treatment After ECT Treatment

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 20, 2018 (Actual)

Primary Completion Date

May 2019 (Anticipated)

Study Completion Date

June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mustafa Kemal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mental Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Sequential Assignment

Model Description

Each drug for one week

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

225 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Paracetamol

Arm Type

Active Comparator

Arm Description

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

Arm Title

Deksketoprofen trometamol

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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 Type

Drug

Intervention Name(s)

Paracetamol

Other Intervention Name(s)

Parol

Intervention Description

The investigators apply paracetamol during a week in preoperative room 45 min before ECT

Intervention Type

Drug

Intervention Name(s)

Deksketoprofen trometamol

Other Intervention Name(s)

Sertofen

Intervention Description

The investigators apply paracetamol during a week in preoperative room 45 min before ECT

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Serum Physiologic

Intervention Description

The investigators apply placebo during a week in preoperative room 45 min before ECT

Primary Outcome Measure Information:

Title

Headache (Visual Analogue Scale 0-10)

Description

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Additive analgesic-antiemetic consumption

Description

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.

Time Frame

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

Title

Adverse effects (Nausea-Vomiting, bradycardia, hypotension)

Description

Number of adverse efffects will be recorded in each interval.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Cagla Buket Akkurt, Prof

Phone

+905053783204

caglabuket@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Onur Koyuncu, Asc.Prof

Organizational Affiliation

Mustafa Kemal Univ.

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sedat Hakimoglu, Asc.Prof

Organizational Affiliation

Mustafa Kemal Univ.

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Senem Urfalı, Ast.Prof

Organizational Affiliation

Mustafa Kemal Univ.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Sumeyra Yesil, Resident

Organizational Affiliation

Mustafa Kemal Univ.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mustafa Kemal University Medicine Faculty Anesthesiology Department

City

Hatay

ZIP/Postal Code

31000

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Onur Koyuncu, Assist. Prof

Phone

5337744757

onurko@yahoo.com

First Name & Middle Initial & Last Name & Degree

Onur Koyuncu, Assoc.Prof

First Name & Middle Initial & Last Name & Degree

Sedat Hakimoglu, Assoc.Prof

First Name & Middle Initial & Last Name & Degree

Senem Urfali, Ast.Prof

First Name & Middle Initial & Last Name & Degree

Sumeyra Yesil, M.D.

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

28754173

Citation

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 electroconvulsive therapy [ECT]. BMC Psychiatry. 2017 Jul 28;17(1):275. doi: 10.1186/s12888-017-1444-6.

Results Reference

result

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Comparison of Drugs on Headache Treatment After ECT Treatment

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