Clinical trial NCT03830398: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mental Disorders
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2019-02-05
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Each drug for one week
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Headache (Visual Analogue Scale 0-10)
timeFrame: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
Secondary outcomes:
measure: Additive analgesic-antiemetic consumption
timeFrame: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
measure: Adverse effects (Nausea-Vomiting, bradycardia, hypotension)
timeFrame: Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Mustafa Kemal University Medicine Faculty Anesthesiology Department
Study officials:
affiliation: Mustafa Kemal Univ.
name: Onur Koyuncu, Asc.Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Mustafa Kemal Univ.
name: Sedat Hakimoglu, Asc.Prof
role: STUDY_CHAIR
affiliation: Mustafa Kemal Univ.
name: Senem Urfalı, Ast.Prof
role: STUDY_DIRECTOR
affiliation: Mustafa Kemal Univ.
name: Sumeyra Yesil, Resident
role: PRINCIPAL_INVESTIGATOR
References:
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.