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Comparison of Drugs on Headache Treatment After ECT Treatment

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

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03830398
Enrollment
225
Registered
2019-02-05
Start date
2018-11-20
Completion date
2019-06-30
Last updated
2019-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Disorders

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.

Interventions

DRUGParacetamol

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

DRUGDeksketoprofen trometamol

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

DRUGPlacebo

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

Sponsors

Mustafa Kemal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

Each drug for one week

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frameDescription
Headache (Visual Analogue Scale 0-10)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

MeasureTime frameDescription
Additive analgesic-antiemetic consumptionPostoperative 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.
Adverse effects (Nausea-Vomiting, bradycardia, hypotension)Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)Number of adverse efffects will be recorded in each interval.

Countries

Turkey (Türkiye)

Contacts

Primary ContactCagla Buket Akkurt, Prof
caglabuket@gmail.com+905053783204

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026