Comparing the analgesic response of intravenous Morphine versus Fentanyl for adult traumatic patients in emergency department

1- To compare the pain reduction between the patients received morphine vs. fentanyl 2- To compare time to lowest pain score between the patients received morphine vs. fentanyl 3- To compare changes in vital sign between the patients received morphine vs. fentanyl 4- To compare the incidence of adverse events between the patients received morphine vs. fentanyl

Parallel group, single blind, randomised controlled trial

The study will be performed on 180 consecutive adult trauma patients with acute pain who were brought to the ED of Nemazee hospital. The sample size will be chosen on the basis of a previous randomized controlled study that compared pain response between opioids. The patients will be selected to use of intravenous opioids according to the judgment of the ED attending physician. Then, they will be randomly allocated to receive a single dose of intravenous morphine (0.1 mg/kg) or fentanyl (5 µg/kg) administered in a single-blind fashion. The patients will not be aware about type of opioids.

Inclusion criteria: Patients who have an initial pain score of 4 or more (0 = no pain and 10 = worst possible pain) on 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. Exclusion Criteria: 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.

Adult trauma patients in the emergency department

The primary outcome measure will be pain reduction on the NRS after administration of morphine or fentanyl; Time to lowest pain score will be also considered as secondary outcome.

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.

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.