Objective: assessment the effect of inhalation and intravenous fentanyl on pain severity of patients with upper or lower limbs fracture. Design: double blind clinical trial Setting and conduct: pain severity will assess in 5, 10, 15, 30 and 60 minutes in both groups. Participants including major eligibility criteria: this study will conduct on 212 patients with trauma in Ahvaz Imam and Gholestan hospitals. Main inclusion criteria age range of 15 to 55 years and having upper and lower limbs fracture and main exclusion criteria include using of antisycotic, sedative, tricyclic antidepressant, selective serotonin reuptake inhibitor, monoamine oxidase inhibitor drugs; having allergy and fentanyl contraindication. Patients will allocate to two equal groups of inhalation and intravenous fentanyl according to table of random numbers. Intervention: patients in intravenous fentanyl group will receive 1 µgr/kg intravenous fentanyl of 50 µgr/ml solution and 5 ml normal saline via inhalation. Patients in inhalation fentanyl group will receive 5 ml intravenous normal saline and 4 µgr/kg fentanyl of 50 µgr/ml solution in combination with 5 ml normal saline via inhalation. Main outcome measures (variables): pain severity
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111425027N1
Registration date:2016-05-11, 1395/02/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-05-11, 1395/02/22
Registrant information
Name
Mohammadreza Maleki Varaki
Name of organization / entity
Ahvaz Judishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3079
Email address
maleki-m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Ahwaz Judishapur University of Medical Sciences
Expected recruitment start date
2015-08-23, 1394/06/01
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of inhalation and intravenous fentanyl on pain severity of patients with limb fracture
Public title
Comparison the effect of inhalation and intravenous fentanyl on pain severity of patients with upper or lower limbs fracture
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age range of 15 to 55 years; having upper and lower limbs fracture. Exclusion criteria: using of antisycotic, sedative, tricyclic antidepressant, selective serotonin reuptake inhibitor, monoamine oxidase inhibitor drugs; having addiction to drugs or opioids; having acute and chronic renal diseases, liver and heart diseases, respiratory diseases (upper and lower respiratory system infection, asthma, chronic obstructive pulmonary diseases); having allergy; being pregnant; fentanyl contraindication.
Age
From 15 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
212
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
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, Khozestan
City
ahvaz
Postal code
15794-61357
Approval date
2014-05-27, 1393/03/06
Ethics committee reference number
IR.AJUMS.REC.1394.136
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
5, 10, 15, 30 and 60 minutes
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Patients in intervention group will receive 1 µgr/kg intravenous fentanyl of 50 µgr/ml solution and 5 ml normal saline via inhalation.
Category
Treatment - Drugs
2
Description
Patients in control group will receive 5 ml intravenous normal saline and 4 µgr/kg fentanyl of 50 µgr/ml solution in combination with 5 ml normal saline via inhalation.