Comparison of Remifentanil with Combined Propofol and Fentanyl Medications for Sedative and Analgesic Effects on Patients with Anterior Shoulder Dislocation Treated by Closed Reduction, A Double-Blind Randomized Clinical Trial

A comparative study on the sedative and analgesic effects of remifentanil and combined propofol and fentanyl in patients with shoulder dislocation

This study is performed on 60 patients referring to the emergency department of Rasht Poursina hospital, with acute anterior shoulder dislocation requiring closed reduction. The patients are placed in two groups by random block method. Random sequences are generated with a 1:1 ratio using the random generator program. Generated sequences or labels A and B are put in sealed envelopes at the emergency nursing station. This study is done in phase three.

This study is performed on the patients of emergency department of Poursina Hospital in Rasht, with shoulder dislocation. After receiving the desired sedative drug (remifentanil or combined fentanyl and propofol), the patients will be examined in terms of success in reducing shoulder joint dislocation, complications (agitation, nausea, vomiting, apnea), pain (score 1 to 10 based on VAS criteria), trouble-free shoulder reduction, the length of stay in the emergency ward for recovery, the duration of the analgesic and sedative effects, and the need for re-injection. The present study is double-blind. An emergency medical specialist working in the hospital gives drugs according to the generated sequences in the same covered encoded syringes to the related residents without having any information on them, and if re-injection is necessary, s(he) will give them the medicine. Also, the patient and the person evaluating the outcome are not aware of the type of injectable drugs.

Inclusion Criteria: The patients referring to the emergency ward of Rasht Poursina hospital, with acute anterior shoulder dislocation requiring closed reduction. Exclusion Criteria: The patients who have been diagnosed with fracture-dislocation of the shoulder joint, except those suffering from Hill-Sachs lesions The patients with decreased Glasgow coma scale (GCS) The patients with immature skeletal system (open epiphysis) or the patients who have undergone surgery beforehand and have had a fracture in the same shoulder The patients who are allergic to soy and eggs The patients with reduced blood pressure The patients with heart failure The patients over the age of 60 and under the age of 15 years

Intervention group: Remifentanil group. A group of patients referring to the emergency ward of Pursina hospital in Rasht, with an acute anterior shoulder dislocation needing closed reduction, taking remifentanil drug for relieving pain. Control group: Combined propofol and fentanyl. A group of patients referring to the Emergency Department of Pursina hospital in Rasht, with acute anterior shoulder dislocation requiring closed reduction, taking combination of propofol and fentanyl for relieving pain.

Side effects; starting time for the reduction after the medication injection; severity of pain; trouble-freeness in joint reduction; stay length in the emergency ward; the need for re-injection of the medication; the duration of analgesic effect after injection

According to the sample size calculated in this study, which equals to 30 patients in each group, they are randomly placed in two groups by random block method. Random sequences are generated with a 1:1 ratio using the random generator program. Generated sequences or labels A and B are put in sealed envelopes at the Emergency Nursing Station.

The present study is double-blind. An emergency medical specialist working in the hospital gives drugs according to the generated sequences in the same covered encoded syringes to the related residents without having any information on them, and if re-injection is necessary, s(he) will give them the medicine. Also, the patient and the person evaluating the outcome are not aware of the type of injectable drugs.