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

Evaluation of analgesic effects of IV metoclopramide versus IV ketorolac in patients with primary acute headache (migraines, tension, cluster) in the emergency department

This is a randomized double-blind comparative efficacy trial. 98 patients were randomized into two groups. Randomization was performed by block randomization (size of 5 for blocks), using an online random number generator. For ethical reasons, there is no placebo arm. The study protocol was confirmed by the Ethical Committee of Ahvaz Jundishapur University of Medical Sciences.

This is study will be done at Golestan and Imam Khomeini hospital of Ahvaz.

Inclusion criteria: Patients referring to the emergency department with acute primary headache (migraine, tension, cluster) with a minimum age of 18 years old and a maximum of 65 years old. Exclusion criteria: Pregnancy, Nursing mothers, Any active bleeding, CHF, MI 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 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.

The patients were randomized into two groups A and B. After receiving the VAS score from them: Group A, 30 mg of ketorolac plus 50 ml of normal saline were infused for 15 minutes. Group B, 10 milligrams of metoclopramide plus 50 ml of normal saline, were infused over 15 minutes. VAS Score, response to treatment and the side effects were assessed within 15, 30 and 60 minutes after receiving medications.

Clinical state, Headache intensity (VAS scoring), Adverse effects.

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

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.