Comparison of Drugs on Headache Treatment After ECT Treatment

NCT ID: NCT03830398

Last Updated: 2019-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-20

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Mental Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Each drug for one week
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Paracetamol

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

Deksketoprofen trometamol

Intervention Type DRUG

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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Paracetamol

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

Intervention Type DRUG

Deksketoprofen trometamol

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Parol Sertofen Serum Physiologic

Eligibility Criteria

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Inclusion Criteria

* All patients who were admitted for ECT and gave informed written consent were included in the study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mustafa Kemal University

OTHER

Sponsor Role lead

Responsible Party

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Onur Koyuncu

Assoc.Prof.MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Onur Koyuncu, Asc.Prof

Role: PRINCIPAL_INVESTIGATOR

Mustafa Kemal Univ.

Sedat Hakimoglu, Asc.Prof

Role: STUDY_CHAIR

Mustafa Kemal Univ.

Senem Urfalı, Ast.Prof

Role: STUDY_DIRECTOR

Mustafa Kemal Univ.

Sumeyra Yesil, Resident

Role: PRINCIPAL_INVESTIGATOR

Mustafa Kemal Univ.

Locations

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Mustafa Kemal University Medicine Faculty Anesthesiology Department

Hatay, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Cagla Buket Akkurt, Prof

Role: CONTACT

+905053783204

Facility Contacts

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Onur Koyuncu, Assist. Prof

Role: primary

5337744757

References

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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.

Reference Type RESULT
PMID: 28754173 (View on PubMed)

Other Identifiers

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2018/171

Identifier Type: -

Identifier Source: org_study_id

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