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Remifentanil for Moderate Sedation for Shoulder Reduction in the ED

Comparison of Remifentanil with Fentanyl/Midazolam for Moderate Sedation for Closed Reduction of Anterior Shoulder Dislocation in Adults in the ED: a Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2013011312115N1
Enrollment
42
Registered
2014-05-11
Start date
2013-02-02
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Anterior Shoulder Dislocation. Glenohumeral Joint

Interventions

Intervention 1: Patients in control group will recieve single dose fentanyl 1.5 microg/kg slowly via intravenous infusion over 30 seconds from the form of injection solution 0.05 mg/ml plus single dos
Treatment - Drugs
Patients in control group will recieve single dose fentanyl 1.5 microg/kg slowly via intravenous infusion over 30 seconds from the form of injection solution 0.05 mg/ml plus single dose midazolam 0.1
In the intervention group the patients will receive remifentanil 1 microg/kg slowly via intravenous injection over 30 seconds and repeated doses every 1 minute titrated to effect from the form of inje

Sponsors

Vice chancellor for research, Mashhad University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: INCLUSION CRITERIA: Those aged 18–64 years with anterior shoulder dislocation, requiring closed reduction with physical condition I (healthy and normal patients without previous medical history) and II (patients with mild systemic disease with no functional limitation) according to the classification system of American Society of Anesthesiologists (ASA) will be selected. EXCLUSION CRITERIA: The exclusion criteria included age 64 years; History of allergy to benzodiazepines and narcotics; Prolonged use of opioids; Alcohol usage; Sleep obstructive apnea syndrome; Maxillofacial malformations with high probability of failure in maintaining the airway; Pregnant patients; Anterior dislocation requiring referral to orthopedic operating room; Patients with severe trauma; Patients in septic shock; Patients with advanced Heart disease; Kidney failure; Pneumonia; Uncontrolled seizures; Patients not willing to participate in the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain Perception. Timepoint: During Intervention. Method of measurement: Visual Analog Scale 100mm.;Respiratory Adverse Events. Timepoint: During Intervention. Method of measurement: The need for supplemental oxygen, Ventilation with a bag-mask, Maneuver practices for maintaining the airway open, Insertion of airway, Respiratory stimulation, Respiratory depression with SpO2 <92% in any time of intravenous administration of the drug until hospital discharge.;Procedure Time. Timepoint: During Intervention. Method of measurement: From the begining of sedatiion till end of reduction.;Patient Consent. Timepoint: After Intervention. Method of measurement: Likert Scale.

Secondary

MeasureTime frame
Non Respiratory Adverse Events. Timepoint: During Intervention. Method of measurement: Dysphoria, Vomiting, Headache, Myoclonus, Nausea, Stiffness, Rash, Cough, Bronchospasm, Laryngospasm, Stridor, Apnea, Seizures, Rash, Restlessness, Aspiration.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZamani Moghadam Hamid

Mashhad Univercity of Medical Science

zamanimh@mums.ac.ir+98 51 1852 5312

Outcome results

None listed

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