NCT03830398

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
225

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2019

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

5 months

First QC Date

January 15, 2019

Last Update Submit

February 2, 2019

Conditions

Mental Disorders

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Additive analgesic-antiemetic consumption

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

  • Adverse effects (Nausea-Vomiting, bradycardia, hypotension)

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

Study Arms (3)

Paracetamol

ACTIVE COMPARATOR

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

Deksketoprofen trometamol

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

Interventions

ParacetamolDRUG

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

Also known as: Parol
Paracetamol
Deksketoprofen trometamolDRUG

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

Also known as: Sertofen
Deksketoprofen trometamol
PlaceboDRUG

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

Also known as: Serum Physiologic
Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who were admitted for ECT and gave informed written consent were included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustafa Kemal University Medicine Faculty Anesthesiology Department

Hatay, 31000, Turkey (Türkiye)

RECRUITING

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

    PMID: 28754173RESULT

MeSH Terms

Conditions

Mental Disorders

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Onur Koyuncu, Asc.Prof

    Mustafa Kemal Univ.

    PRINCIPAL INVESTIGATOR

  • Sedat Hakimoglu, Asc.Prof

    Mustafa Kemal Univ.

    STUDY CHAIR

  • Senem Urfalı, Ast.Prof

    Mustafa Kemal Univ.

    STUDY DIRECTOR

  • Sumeyra Yesil, Resident

    Mustafa Kemal Univ.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cagla Buket Akkurt, Prof

CONTACT

+905053783204caglabuket@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: Each drug for one week
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof.MD

Study Record Dates

First Submitted

January 15, 2019

First Posted

February 5, 2019

Study Start

November 20, 2018

Primary Completion

May 1, 2019

Study Completion

June 1, 2019

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations

TU(1)