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The role of dexmedethomidine in sedation and analgesia in the emergency department

Comparison of the combination of dexmedethomidine and fentanyl with midazolam and fentanyl in induction of sedation and analgesia for reduction of distal radial fracture in the emergency department

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20160401027165N1
Enrollment
40
Registered
2018-01-13
Start date
2014-04-22
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

distal radial fracture. Injury to the wrist and hand

Interventions

Intervention 1: Intervention group: the first group, in this group midazolam (Darupakhsh Co, Iran) was given with dose of 0.1 mg /kg, and Fentanyl (Abu Rayhan CO, Iran),with dose of 3 µg/kg with wit
Treatment - Drugs
Intervention group: the first group, in this group midazolam (Darupakhsh Co, Iran) was given with dose of 0.1 mg /kg, and Fentanyl (Abu Rayhan CO, Iran),with dose of 3 µg/kg with with titarting dose
Intervention group: The second group, in this group, dexmedethomidine (Huspiria of USA, Behestan Daroba) was given with a dose of 1 mg/kg with 10-minute intravenous infusion and fetanyl(Abu Ravihan

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: All patients aged 18 to 60 years old who referred to the emergency department with a distal radial fracture

Exclusion criteria

Exclusion criteria: patient who taking antihypertensive or antihistaminic drugs patient aged less than 18 years Severe associated injury include: Head trauma and deceased level of consciousness (GCS <15), Severe chest trauma Cervical spine trauma with unstable fracture Patients with hemodynamic instability Patients with mental retardation Patients with a history of heart disease (bradycardia and any AV heart block) pregnant patient history of allergy to midazolam, fentanyl and dexmedethomidine addiction to opioids and substance abuse

Design outcomes

Primary

MeasureTime frame
Pain. Timepoint: Before inducing sedation and analge- After the procedure and complete awakining. Method of measurement: Visual analog scale(VAS).;Hypertension. Timepoint: Before, during and immediately after the completion of procedure. Method of measurement: Electronic barometric( Saadat Factory).;Heat rate. Timepoint: Before, during and immediately after the completion of procedure. Method of measurement: Electronic Monitor( Saadat Factory).;SPO2. Timepoint: Before, during and immediately after the completion of procedure. Method of measurement: Electronic Pulsoximer( Saadat Factory).;Respiratory rate. Timepoint: Before, during and immediately after the completion of procedure. Method of measurement: Clinical examination(Obsevation).

Secondary

MeasureTime frame
Apnea. Timepoint: during and immediately after the completion of procedure. Method of measurement: close observation.;Bradycardia. Timepoint: during and immediately after the completion of procedure. Method of measurement: Electronic Monitor( Saadat Factory).;Nausea and vomiting. Timepoint: during and immediately after the completion of procedure. Method of measurement: close obsevation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAli Arhami Dolatabadi

Shahid Beheshti University of Medical Sciences

aliarhami@sbmu.ac.ir+98 21 7443 2380

Outcome results

None listed

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