Objective: assessment the effect of intranasal ketamine hydrochloride and intravenous morphine sulfate on pain severity of patients with upper or lower limbs fracture.
Design: clinical trial without blinding
Randomization: patients will allocate to two equal groups of intranasal ketamine hydrochloride and intravenous morphine sulfate according to table of random numbers.
Participants including major eligibility criteria: this study will conduct on 104 patients with trauma in Ahvaz Imam Khomaieni and Gholestan hospitals. Main inclusion criteria include age range of 15 to 64 years and having upper and lower limbs fracture, and main exclusion criteria include low of consciousness; hemodynamic instability; addiction to drugs or opioids; mental retardation and psychosis; chronic cardiovascular diseases; being pregnant and breastfeeding; intranasal ketamine hydrochloride and intravenous morphine sulfate contraindication.
Intervention: patients in intranasal ketamine hydrochloride group will receive 1 mg/kg ketamine hydrochloride of 10 ml solution (which put in sterile nasal drop bottle) via inhalation. Patients in intravenous morphine sulfate group will receive 0.1 mg/kg morphine sulfate via intravenous.
Main outcome measures (variables): pain severity
Setting and conduct: pain severity will assess in 0, 5, 10, 15, 20, 25, and 30 minutes in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016031027007N1
Registration date:2016-05-28, 1395/03/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-28, 1395/03/08
Registrant information
Name
Somayyeh Gharibi
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 613333333
Email address
gharibi.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahwaz Judishapur University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion the effect of intranasal ketamine hydrochloride and intravenous morphine sulfate on pain severity of patients with limb fracture
Public title
Comparison the effect of intranasal ketamine hydrochloride and intravenous morphine sulfate on pain severity of patients with upper or lower limbs fracture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age range of 15 to 64 years; having upper and lower limbs fracture. Exclusion criteria: low of consciousness; hemodynamic instability; addiction to drugs or opioids; mental retardation and psychosis; chronic cardiovascular diseases; being pregnant and breastfeeding; intranasal ketamine hydrochloride and intravenous morphine sulfate contraindication.
Age
From 15 years old to 64 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khuzestan
City
Ahvaz
Postal code
6135715794
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.AJUMS.REC.1394.338
Health conditions studied
1
Description of health condition studied
Pain
ICD-10 code
M79.6
ICD-10 code description
Pain in limb
Primary outcomes
1
Description
Pain severity
Timepoint
Before intervention and 5, 10, 15, 20, 25 and 30 minutes after intervention
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Vital sign
Timepoint
Before intervention and 5, 10, 15, 20, 25 and 30 minutes after intervention
Method of measurement
Cardiopulmonary monitoring
Intervention groups
1
Description
Patients in intranasal ketamine hydrochloride group will receive 1 mg/kg ketamine hydrochloride of 10 ml solution (which put in sterile nasal drop bottle) via inhalation.
Category
Treatment - Drugs
2
Description
Patients in intravenous morphine sulfate group will receive 0.1 mg/kg morphine sulfate via intravenous