Comparison of dexmedetomidine-alfentanyl vs ketamine-alfentanyl for closed reduction of nasal bone fracture
Design
Randomized double blinded clinical trial with two factorial group
Settings and conduct
Sixty patients, 15–40 years old, who were scheduled for close reduction of nasal bone fracture with sedation in Ahvas Imam khomeini hospital, were enrolled in this randomized and double-blinded study. Patients were randomly assigned into two groups of 30 patients. Group A received dexmedetomidine-alfentanyl and Group B received ketamine-alfentanyl intravenously
Participants/Inclusion and exclusion criteria
fracture time less than 72 hours and no comorbidity
Intervention groups
dexmedetomidine-alfentanyl group and ketamine-alfentanyl group
Main outcome variables
VAS pain score, sBp, dBp, MAP, heart rate, recovery time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191127045530N1
Registration date:2019-12-31, 1398/10/10
Registration timing:registered_while_recruiting
Last update:2019-12-31, 1398/10/10
Update count:0
Registration date
2019-12-31, 1398/10/10
Registrant information
Name
Fahimeh Elyasinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3392 5882
Email address
elyasinia.fahimeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-24, 1398/09/03
Expected recruitment end date
2020-01-23, 1398/11/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of dexmedetomidine-alfentanyl vs ketamine-alfentanyl for closed reduction of nasal bone fracture
Public title
Comparison of dexmedetomidine-alfentanyl vs ketamine-alfentanyl for closed reduction of nasal bone fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
fracture less than 72 hours
15 - 40 years range
Exclusion criteria:
co morbidity
Age
From 15 years old to 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Our method is simple randomization and assign subjects into two groups A and B. We assign subjects to each group randomly based on last digit of his or her number of hospital's file for every assignment. We put Even numbers into group A dexmedetomidine-alfentanyl and odd numbers into group B ketamine-alfentanyl.
Blinding (investigator's opinion)
Double blinded
Blinding description
volunteers are not aware of the type of drugs are used for anesthesia .Also data collectors and data analysts do their job only with the name of A and B for both groups and about the drug content of groups are unaware.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz jondishapour University of Medical Sciences
Street address
No233, Isfehan Ave; golestan Blvd; Ahvaz town
City
Ahvaz
Province
Khouzestan
Postal code
6136834498
Approval date
2019-11-23, 1398/09/02
Ethics committee reference number
IR.AJUMS.REC.1398.624
Health conditions studied
1
Description of health condition studied
Nasal bone fracture
ICD-10 code
S02.2XXA
ICD-10 code description
Fracture of nasal bones, initial encounter for closed fracture
Primary outcomes
1
Description
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
2
Description
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
3
Description
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
4
Description
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
Secondary outcomes
1
Description
Awakening time
Timepoint
Awakening time
Method of measurement
Ramsay sedation score
2
Description
Discharge from recovery
Timepoint
Discharge from recovery
Method of measurement
Modified Alderete Score
3
Description
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)
4
Description
Satisfaction of patient and surgeon
Timepoint
min1 ,min5,min 15,recovery ,2 hours later,4 hours later