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Comparison of midazolam/fentanyl and thiopental/ fentanyl for fracture and dislocation reduction of upper arm

Comparison of intravenous sedation with midazolam/fentanyl and thiopental/ fentanyl for orthopedic procedures of upper extremities

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT201110307751N2
Enrollment
92
Registered
2012-04-17
Start date
2011-06-22
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

Condition 1: Dislocation of shoulder joint. Condition 2: Fracture of lower end of both ulna and radius. Dislocation of shoulder joint Fracture of lower end of both ulna and radius

Interventions

In control group thiopental (2 mg/kg) and fentanyl (1.5 mg/kg) is used and compared with midazolam (0.1-0.5 mg/kg) and fentanyl (1.5 mg/kg). In case of needing additional doses, half of the first dos
Treatment - Drugs

Sponsors

Tehran Universty of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Orthopedic injuries of upper extremities in 15-60 years old patients with American Society of Anesthesiologist (ASA) Classification Score 1& 2 Exclusion criteria: Pregnancy, multiple trauma or fractures, history of allergic reaction to study drugs,or asthma, heart failure, porphyria, mental disorders or psychosis

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Pain score. Timepoint: before procuder,on time procuder,5 minut after procuder,15 minut after procuder. Method of measurement: numeric rating scale.

Secondary

MeasureTime frame
BP. Timepoint: Before procedure,on time procedure,end of procedure,5 and 15 minute of procedure. Method of measurement: Osillometry.;SaO2. Timepoint: Before procedure,on time procedure,end of procedure,5 and 15 minute of procedure. Method of measurement: Puls oxymetry.;HR. Timepoint: Before procedure,on time procedure,end of procedure,5 and 15 minute of procedure. Method of measurement: Cardiac monitoring.;Pain. Timepoint: Before procedure,on time procedure,end of procedure,5 and 15 minute of procedure. Method of measurement: Numeric rating scale.

Countries

Iran (Islamic Republic of)

Outcome results

None listed

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