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Comparison of the sedative and analgesic effects of intranasal dexmedetomidine, fentanyl and ketamine in outpatient orthopedic procedure in children

Comparison of the sedative and analgesic effects of intranasal dexmedetomidine, fentanyl and ketamine in outpatient orthopedic procedure in children

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20141209020258N199
Enrollment
120
Registered
2025-08-02
Start date
2025-08-11
Completion date
Unknown
Last updated
2025-08-19

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

Conditions

orthopedic procedures in pediatrics. Fracture of unspecified body region

Interventions

Intervention 1: Intervention group: 2 mcg/kg of Dexmedetomidine (Medox – Exir Pharmaceutical Company, Iran) will be administered intranasally 60 minutes before anesthesia induction. Intervention 2: In

Sponsors

Arak University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 7 Years

Inclusion criteria

Inclusion criteria: Children aged 2 to 7 years Candidates for orthopedic outpatient procedures (casting and splinting of limbs) Establishment of IV line in the orthopedic department for all patients prior to entering the operating room Absence of underlying diseases such as heart, lung, and kidney disease No known allergies to the medications used Parental consent to participate in the study

Exclusion criteria

Exclusion criteria: Refusal to participate in the study Failure to achieve the required pain relief and sedation using the studied method

Design outcomes

Primary

MeasureTime frame
Sedation. Timepoint: Every 15 minutes to one hour post-surgery. Method of measurement: Observer's Assessment of Alertness/Sedation (OAA/S) Scale.;Anxiety. Timepoint: Every 15 minutes to one hour post-surgery. Method of measurement: On a scale of 1 to 4, where 1 is calm and 4 is highly anxious, resistant, and crying.;Agitation. Timepoint: Every 15 minutes to one hour post-surgery. Method of measurement: A three-point adapted scale from 1 (calm children) to 3 (children who were hitting and could not be calmed with language).;Pain. Timepoint: Every 15 minutes to one hour post-surgery. Method of measurement: Children's Hospital of Eastern Ontario Pain Scale (CHEOPS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Alireza Kamali

Arak University of Medical Sciences

alikamaliir@yahoo.com+98 68 3222 2003

Outcome results

None listed

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