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IRCT20180608040013N1 IRCT 2019-07-17 Shiraz University of Medical Sciences Pain control with intravenous Morphine versus Fentanyl in adult traumatic patients Comparing the analgesic response of intravenous Morphine versus Fentanyl for adult traumatic patients in emergency department 2018-06-22 anticipated 180 Complete https://irct.ir/trial/36564 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We used block randomization in the current study. Each block size was 2 by 2, and totally 45 blocks were considered. The acceptable sequences for packages within each block were: 1) AABB, 2) ABAB, 3) BBAA, 4) BABA, 5) ABBA, and 6) BAAB. Then each of them had been marked from 1 to 6 as above. After that, the packages within blocks were sequentially numbered from 1 to 180. Participant were consecutively numbered from 1 to 180, based on the time of admission and hospital registration code. Allocation was performed by blindly matching the patients’ number and package. Randomization sequence and concealment were performed by emergency medicine attending. Allocation and matching of the participants’ number to the package number in order to receive the intervention was performed by emergency medicine resident, Blinding description: Two set of 90 sterile, colorless and ready to inject 10cm3 syringes were prepared and name syringe A (morphine) and syringe B (fentanyl) before concealment. According to block randomization, each patients were received syringe A or B. So, the patients, physicians, nurses, as well as data analyzer were blinded to kind of analgesics were used. 3 Adult traumatic patients. Intervention 1: Intervention group: A single dose of intravenous morphine (0.1 mg/kg). Intervention 2: Control group: A single dose of intravenous fentanyl (5 µg/kg). 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 I have not thought about it yet
public Najmeh Zarei Jelyani
Karim Khan-e-Zand Ave, Namazi hospital
Shiraz Iran (Islamic Republic of) 7186836388 +98 71 3630 2747 n_zarei@sums.ac.ir Shiraz University of Medical Sciences scientific Najmeh Zarei Jelyani
Namazi hospital
Shiraz Iran (Islamic Republic of) 7186836388 +98 71 3630 2747 n_zarei@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients who have an initial pain score of 4 or more (0 = no pain and 10 = worst possible pain) according to the Numerical Rating Scale (NRS) upon presentation. Age more than 18 years Initial oxygen saturation greater than 95% Patients with a GCS score of 15 18 years no limit Both Systolic blood pressure less than 90 mmHg Known pregnancy Patients with chronic pain syndromes (such as sickle cell disease or fibromyalgia) Cognitive impairment Known allergy to either fentanyl or morphine Treatment - Drugs Treatment - Drugs Intervention group: A single dose of intravenous morphine (0.1 mg/kg) Control group: A single dose of intravenous fentanyl (5 µg/kg) Pain reduction based on the Numerical Rating Scale (NRS). Timepoint: At baseline, 5, 10, 30, 120 minutes post baseline. Method of measurement: Numerical Rating Scale (NRS). Time to lowest pain score. Timepoint: From baseline to 2 hours post baseline. Method of measurement: Stopwatch. Shiraz University of Medical Sciences Approved 2018-06-18 Ethics committee of Shiraz University of Medical Sciences Karim khan zand Ave, Shiraz University of Medical Sciences Shiraz Fars Iran (Islamic Republic of)