Comparison of Drugs on Headache Treatment After ECT Treatment

Study Overview
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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.

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

Conditions
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Mental Disorders

Intervention / Treatment
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* Drug: Paracetamol
* Drug: Deksketoprofen trometamol
* Drug: Placebo


Participation Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Each drug for one week
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Paracetamol<br>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<br>* The investigators apply paracetamol during a week in preoperative room 45 min before ECT<br>* Other names: Parol;|
| Active Comparator: Deksketoprofen trometamol<br>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<br>* The investigators apply paracetamol during a week in preoperative room 45 min before ECT<br>* Other names: Sertofen;|
| Placebo Comparator: Placebo<br>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<br>* The investigators apply placebo during a week in preoperative room 45 min before ECT<br>* Other names: Serum Physiologic;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention) | 
| Adverse effects (Nausea-Vomiting, bradycardia, hypotension) | Number of adverse efffects will be recorded in each interval. | Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention) |