Comparison of Drugs on Headache Treatment After ECT Treatment
Keywords
Abstract
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.
Dates
| Last Verified: | 01/31/2019 |
| First Submitted: | 01/14/2019 |
| Estimated Enrollment Submitted: | 02/01/2019 |
| First Posted: | 02/04/2019 |
| Last Update Submitted: | 02/01/2019 |
| Last Update Posted: | 02/04/2019 |
| Actual Study Start Date: | 11/19/2018 |
| Estimated Primary Completion Date: | 04/30/2019 |
| Estimated Study Completion Date: | 05/31/2019 |
Condition or disease
Intervention/treatment
Drug: Paracetamol
Drug: Deksketoprofen trometamol
Drug: Placebo
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| 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 The investigators apply paracetamol during a week in preoperative room 45 min before ECT |
| 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 The investigators apply paracetamol during a week in preoperative room 45 min before ECT |
| 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 The investigators apply placebo during a week in preoperative room 45 min before ECT |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
Primary Outcome Measures
1. Headache (Visual Analogue Scale 0-10) [Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)]
Secondary Outcome Measures
1. Additive analgesic-antiemetic consumption [Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)]
2. Adverse effects (Nausea-Vomiting, bradycardia, hypotension) [Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention)]
