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Comparison of Remifentanil with Combined Propofol and Fentanyl Medications for Sedative and Analgesic Effects in the Treatment of Shoulder Dislocation

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20110818007369N6
Enrollment
60
Registered
2018-02-21
Start date
2017-10-23
Completion date
Unknown
Last updated
2018-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anterior shoulder dislocation. Unspecified subluxation and dislocation of shoulder joint

Interventions

Intervention 1: Intervention group: Remifentanil (1 µg/kg) will be injected intravenously. Remifentanil (0.5 µg/kg) can be repeated three times at the most, and if needed, the drug will be injected a

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 60 Years

Inclusion criteria

Inclusion criteria: The patients referring to the emergency department of Poursina hospital with acute anterior shoulder dislocation requiring closed reduction

Exclusion criteria

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 GCS and unstable hemodynamic status The patients with immature skeletal system (open epiphysis) or the patients who have undergone surgery previously and have had a fracture in the same shoulder The patients who are allergic to soy and eggs The patients with reduced blood pressure (Systolic Blood Pressure<90 mm Hg) The patients with heart failure The patients over the age of 60 and under the age of 15 years

Design outcomes

Primary

MeasureTime frame
Amount of side effects following drug injection such as agitation, nausea, vomiting, and apnea. Timepoint: 1, 5, 10 and 20 minutes after shoulder reduction. Method of measurement: Based on the resident report.;Starting time of reduction after the drug injection. Timepoint: 1, 5, 10 and 20 minutes after shoulder reduction. Method of measurement: Since drug injection until patient sedation in seconds.;Severity of pain. Timepoint: 1, 5, 10 and 20 minutes after shoulder reduction. Method of measurement: The severity of pain before, during, and after joint reduction is measured according to the visual analogue scale based on the patient's statement.;Amount of trouble-freeness in the shoulder joint reduction. Timepoint: 1, 5, 10 and 20 minutes after shoulder reduction. Method of measurement: Based on the resident report.;Stay length in the emergency ward. Timepoint: 1, 5, 10 and 20 minutes after shoulder reduction. Method of measurement: Since the beginning of injection until the end of the recovery (full consciousness) in the patient in minutes.;The need for re-injection of the drug. Timepoint: 1, 5, 10 and 20 minutes after shoulder reduction. Method of measurement: The inadequacy of the sedative and analgesic effects leading to re-inject repeated dose of the drug.;Duration analgesic effect after the drug injection. Timepoint: 1, 5, 10 and 20 minutes after shoulder reduction. Method of measurement: Duration of the sedative and analgesic effects after the injection in minutes.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMarjan Aghajani Nargesi

Rasht University of Medical Sciences

info@gtrc.ir+98 13 3377 4858

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026