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IRCT20151103024853N4 IRCT 2020-08-13 Ahvaz University of Medical Sciences Evaluation of analgesic effects of intravenous metoclopramide versus intravenous ketorolac in patients with primary acute headache Evaluation of analgesic effects of intravenous metoclopramide versus intravenous ketorolac in patients with primary acute headache (migraines, tension, cluster) in emergency department: a double-blind clinical trial 2019-02-20 anticipated 98 Complete https://irct.ir/trial/37509 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients were randomized into two groups A (Ketorolac) and B (Metoclopramide) based on a table of random numbers. Randomization was performed by block randomization (size of 6 for blocks), using online random number generator (Sealed Envelope) https://www.sealedenvelope.com/simple-randomiser/v1/lists. An independent pharmacist performed randomization in blocks of 6 using an online random number generator. the pharmacist filled syringes with each medication and placed them into sequentially numbered sealed envelopes in the order determined by randomization. The contents of these syringes were clear and indistinguishable. The research associates used these medication envelopes consecutively as successive patients enrolled in the study. Only the pharmacist, who was not in the ED, and whose records were maintained in a distant location, knew the randomly allocated assignments. Input Data: Seed: 29346974825611 Treatment groups: Group A, Group B Block sizes: 6 List length: 200 Output Data: Example 34, 6, 6, Group B, Blinding description: An independent pharmacist performed randomization in blocks of 6 using an online random number generator. the pharmacist filled syringes with each medication and placed them into sequentially numbered sealed envelopes in the order determined by randomization. The contents of these syringes were clear and indistinguishable. The research associates used these medication envelopes consecutively as successive patients enrolled in the study. Only the pharmacist, who was not in the ED, and whose records were maintained in a distant location, knew the randomly allocated assignments. 3 Condition 1: Migraine. Condition 2: Tension-type headache. Condition 3: Cluster headaches. Intervention 1: Intervention group: After receiving the baseline VAS score from patients, 30 mg ketorolac plus 50 ml of normal saline were infused for 15 minutes. VAS Score, response to treatment and the side effects were assessed within 15, 30 and 60 minutes after receiving medication. Intervention 2: Intervention group: After receiving the baseline VAS score from patients, 10 mg metoclopramide plus 50 ml of normal saline were infused for 15 minutes. VAS Score, response to treatment and the side effects were assessed within 15, 30 and 60 minutes after receiving medication. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Dr. Leila Kouti
Ahvaz Faculty of Pharmacy, Golestan street, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8380 lkouti.pharmacotherapy@gmail.com Ahvaz University of Medical Sciences scientific Dr. Leila Kouti
Ahvaz Faculty of Pharmacy, Golestan street, Ahvaz
Ahvaz Iran (Islamic Republic of) 6135715794 +98 61 3373 8380 lkouti.pharmacotherapy@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Patients referring to the emergency department with acute primary headache (migraine, tension, cluster) Age: minimum 18 years old and maximum 65 years old 18 years 65 years Both Pregnancy Nursing mothers Any active bleeding CHF (Congestive Heart Failure) MI (Myocardial Infarction) history Parkinson or history of any Extrapyramidal Side Effects Pheochromocytoma Epilepsy and history of seizure History of Depression Allergy to experimented drugs Painkillers administration before admission to the Emergency Department (ED) ‌‌Systolic Blood pressure under 90mmHg or above 180mmHg Heart rate under 50 beats/min or above 150 beats/min Patients taking Antipsychotics, Promethazine, MAO inhibitors, Rivastigmine G43 G44.2 G44.0 Migraine Tension-type headache Cluster headaches and other trigeminal autonomic cephalgias (TAC) Treatment - Drugs Treatment - Drugs Intervention group: After receiving the baseline VAS score from patients, 30 mg ketorolac plus 50 ml of normal saline were infused for 15 minutes. VAS Score, response to treatment and the side effects were assessed within 15, 30 and 60 minutes after receiving medication. Intervention group: After receiving the baseline VAS score from patients, 10 mg metoclopramide plus 50 ml of normal saline were infused for 15 minutes. VAS Score, response to treatment and the side effects were assessed within 15, 30 and 60 minutes after receiving medication. Pain Visual Analogue Scale (VAS Scoring). Timepoint: Baseline, 15, 30, 60 minutes after intervention. Method of measurement: 10-cm visual analog pain scale. Patients achieved headache freedom in the ED without requiring rescue medication. Timepoint: 60 minutes after intervention. Method of measurement: Patients own statement of Headache freedom. Patients that required rescue medication in the ED. Timepoint: 60 minutes after intervention. Method of measurement: Minor headache improvement in patients with the discretion of the treating physician. Ahvaz University of Medical Sciences Approved 2019-01-19 Ethics committee of ahvaz University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan blvd., Ahvaz Ahvaz Khouzestan Iran (Islamic Republic of)