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Status unknownNCT03830398Updated Feb 5, 2019

Comparison of Drugs on Headache Treatment After ECT Treatment

A Phase 4 interventional study of Paracetamol and Deksketoprofen trometamol in Mental Disorders, sponsored by Mustafa Kemal University. Status unknown at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-02-05.

Sponsored by Mustafa Kemal University · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
225
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Mental Disorders

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03

In context

Mental Disorders

2,148 studies on the registry are indexed under Mental Disorders; 425 are open to participants now.

This study's planned enrollment of 225 is above the median of 96 across 1,607 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Mustafa Kemal University is the lead sponsor of 75 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
225 participants (estimated)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugParacetamol

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

    Also known as: Parol

  • DrugDeksketoprofen trometamol

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

    Also known as: Sertofen

  • DrugPlacebo

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

    Also known as: Serum Physiologic

06

What researchers measure

Primary outcomes

  1. Headache (Visual Analogue Scale 0-10)

    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 outcomes

  1. 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.

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

  2. Adverse effects (Nausea-Vomiting, bradycardia, hypotension)

    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)

07

Study locations

1 of 1 sites recruiting
  • Mustafa Kemal University Medicine Faculty Anesthesiology Department
    Hatay, 31000, Turkey (Türkiye)
    • Onur Koyuncu, Assist. Prof · Contact · onurko@yahoo.com · 5337744757
    • Onur Koyuncu, Assoc.Prof · Principal investigator
    • Sedat Hakimoglu, Assoc.Prof · Sub investigator
    • Senem Urfali, Ast.Prof · Sub investigator
    • Sumeyra Yesil, M.D. · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 28754173 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2018 (actual). Primary completion is estimated for May 2019, 6 months after the start.

Of 27 phase 4 interventional studies under Mental Disorders, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 64. This study's planned 6 months is below that.

Mental Disorders covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 15, 2019
First posted
Feb 5, 2019
StartActual
Nov 20, 2018
Primary completionEst.
May 2019
CompletionEst.
Jun 2019
Last update
Feb 5, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03830398
Lead sponsor
Mustafa Kemal University
Responsible party
Onur Koyuncu (Assoc.Prof.MD, Mustafa Kemal University) — Principal investigator
First posted
Feb 5, 2019
Start date
Nov 20, 2018
Primary completion
May 2019 (estimated)
Completion
Jun 2019 (estimated)
Last update
Feb 5, 2019

Study contacts

Cagla Buket Akkurt, Prof
Contact
caglabuket@gmail.com
+905053783204
Onur Koyuncu, Asc.Prof
principal investigator · Mustafa Kemal Univ.
Sedat Hakimoglu, Asc.Prof
study chair · Mustafa Kemal Univ.
Senem Urfalı, Ast.Prof
study director · Mustafa Kemal Univ.
Sumeyra Yesil, Resident
principal investigator · Mustafa Kemal Univ.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Acetaminophen

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