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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracetamol | Active Comparator | 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 |
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| Deksketoprofen trometamol | Active Comparator | 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 |
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| Placebo | Placebo Comparator | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | The investigators apply paracetamol during a week in preoperative room 45 min before ECT |
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| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cagla Buket Akkurt, Prof | Contact | +905053783204 | caglabuket@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Onur Koyuncu, Asc.Prof | Mustafa Kemal Univ. | Principal Investigator |
| Sedat Hakimoglu, Asc.Prof | Mustafa Kemal Univ. | Study Chair |
| Senem Urfalı, Ast.Prof |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mustafa Kemal University Medicine Faculty Anesthesiology Department | Recruiting | Hatay | 31000 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28754173 | Result | 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. |
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| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Each drug for one week
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| Deksketoprofen trometamol | Drug | The investigators apply paracetamol during a week in preoperative room 45 min before ECT |
|
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| Placebo | Drug | The investigators apply placebo during a week in preoperative room 45 min before ECT |
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Number of adverse efffects will be recorded in each interval. |
| Postoperative 2. hour, 4. hour, 6. hour (up to six hours after intervention) |
| Mustafa Kemal Univ. |
| Study Director |
| Sumeyra Yesil, Resident | Mustafa Kemal Univ. | Principal Investigator |
| Aniline Compounds |
| D000588 | Amines |