Comparison of dexmedetomidine-alfentanyl vs ketamine-alfentanyl for closed reduction of nasal bone fracture

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191127045530N1

Enrollment

Registered

2019-12-31

Start date

2019-11-24

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

Nasal bone fracture. Fracture of nasal bones, initial encounter for closed fracture

Interventions

Intervention 1: Intervention group: dexmedethomidine 1 µg/kg Exir- alfentanil 8µg/kg Daroupakhsh. Intervention 2: Intervention group: ketamine mg/kg 1 Exir- alfentanil 8µg/kg Daroupakhsh.

Eligibility

Sex/Gender

All

Age

15 Years to 40 Years

Inclusion criteria

Inclusion criteria: fracture less than 72 hours 15 - 40 years range

Exclusion criteria

Exclusion criteria: co morbidity

Design outcomes

Primary

Measure	Time frame
Systolic blood pressure. Timepoint: Before intervention,1 min later,5 min later,15 min later,recovery,2 hours later,4 hours later. Method of measurement: sphygmomanometer.;Diastolic blood pressure. Timepoint: Before intervention,1 min later,5 min later,15 min later,recovery,2 hours later,4 hours later. Method of measurement: sphygmomanometer.;Mean arterial pressure. Timepoint: Before intervention,1 min later,5 min later,15 min later,recovery,2 hours later,4 hours later. Method of measurement: sphygmomanometer.;Pain score. Timepoint: Before intervention,1 min later,5 min later,15 min later,recovery,2 hours later,4 hours later. Method of measurement: Visual Analogue Scale.	—

Measure

Time frame

Systolic blood pressure. Timepoint: Before intervention,1 min later,5 min later,15 min later,recovery,2 hours later,4 hours later. Method of measurement: sphygmomanometer.;Diastolic blood pressure. Timepoint: Before intervention,1 min later,5 min later,15 min later,recovery,2 hours later,4 hours later. Method of measurement: sphygmomanometer.;Mean arterial pressure. Timepoint: Before intervention,1 min later,5 min later,15 min later,recovery,2 hours later,4 hours later. Method of measurement: sphygmomanometer.;Pain score. Timepoint: Before intervention,1 min later,5 min later,15 min later,recovery,2 hours later,4 hours later. Method of measurement: Visual Analogue Scale.

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Secondary

Measure	Time frame
Awakening time. Timepoint: Awakening time. Method of measurement: Ramsay sedation score.;Discharge from recovery. Timepoint: Discharge from recovery. Method of measurement: Modified Alderete Score.;Agitation. Timepoint: Before intervention,min 1 ,min 5 ,min 15,recovery,2 hours later,4 hours later. Method of measurement: Modified obsevers assessment of alertness/sedation scale(MOAA/S).;Satisfaction of patient and surgeon. Timepoint: min1 ,min5,min 15,recovery ,2 hours later,4 hours later. Method of measurement: 7 point likert like verbal rating scale.	—

Measure

Time frame

Awakening time. Timepoint: Awakening time. Method of measurement: Ramsay sedation score.;Discharge from recovery. Timepoint: Discharge from recovery. Method of measurement: Modified Alderete Score.;Agitation. Timepoint: Before intervention,min 1 ,min 5 ,min 15,recovery,2 hours later,4 hours later. Method of measurement: Modified obsevers assessment of alertness/sedation scale(MOAA/S).;Satisfaction of patient and surgeon. Timepoint: min1 ,min5,min 15,recovery ,2 hours later,4 hours later. Method of measurement: 7 point likert like verbal rating scale.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFahimeh Elyasinia

Ahvaz University of Medical Sciences

elyasinia.fahimeh@gmail.com+98 61 3222 2922

Outcome results

None listed

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