Skip to content

Study of the analgesic effects of intranasal dexmedetomidine in trauma patients

Comparison of analgesic and sedative effects of intranasal dexmedetomidine with IV/IM ketorolac in isolated limb trauma patients

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20251028067801N1
Enrollment
90
Registered
2025-12-19
Start date
2025-12-22
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

isolated limb trauma patients.

Interventions

Intervention 1: Dexmedetomidine group: (Receive 100 micrograms in 1 cc of intranasal dexmedetomidine and 1 cc of normal saline IV/IM).To administer dexmedetomidine intranasally, the injectable form of

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients with isolated limb trauma with pain intensity of at least 4 on the numeric rating scale (NRS) Age between 18 and 65 years weight between 50 -100 kg

Exclusion criteria

Exclusion criteria: Known history of sleep apnea Alcohol-consuming patients Known history of liver failure or icteric appearance Known history of renal failure (according to medical and/or drug history) Known history of heart failure or class 4 shortness of breath Known history of allergy to dexmedetomidine, ketorolac, and morphine Pregnancy and breastfeeding Patients who have recently taken painkillers within the past 6 hours nasal congestion Patients using opioids Oxygen level less than 92% in room air MAP <65 and/or systolic pressure <90 Respiratory rate less than 12 Heart rate less than 60 The need for any intervention requiring the prescription of sleeping pills Patients with any difficulty communicating with the medical staff

Design outcomes

Primary

MeasureTime frame
Number of patients requiring additional analgesic(morphine) in the group of patients with moderate pain (score 4 to 6 based on the numeric rating scale). Timepoint: Within 3 hours after administration of drugs. Method of measurement: Patient file.;Cumulative dose of morphine consumed in all patients. Timepoint: Within 3 hours after administration of drugs. Method of measurement: Drug miligram from Patient file.;Most changes in restlessness compared to baseline. Timepoint: Within 3 hours after administration of drugs. Method of measurement: Richmond agitation and sedation scale RASS.;Changes in pain intensity compared to baseline. Timepoint: Half an hour, one hour, 2 hours and 3 hours after administration of first drug. Method of measurement: Numeric rating scale.

Secondary

MeasureTime frame
Number of patients with MAP reduction to less than 65 or SBP<90. Timepoint: Every 15 to 30 minutes Within 3 hours after administration of drugs. Method of measurement: cardiac monitor.;Number of patients with heart rate reduction below 50. Timepoint: Every 15 to 30 minutes Within 3 hours after administration of drugs. Method of measurement: pulsoximeter/cardiac monitor.;Number of patients with oxygen saturation levels below 90%. Timepoint: Every 15 to 30 minutes Within 3 hours after administration of drugs. Method of measurement: pulsoximeter/cardiac monitor.;Number of patients with respiratory rate reduced to less than 10. Timepoint: Every 15 to 30 minutes Within 3 hours after administration of drugs. Method of measurement: cardiac monitor.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh sadat Hosseini

Tehran University of Medical Sciences

sadie959595@yahoo.com+98 21 7679 1396

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026