the comparison of the effect of nebulizer of fentanyl and intravenous morphine in controlling the pain of patients with fracture of long bone referring to Ayatollah Moosavi hospital in Zanjan
Design
Clinical trial with control group, with parallel groups, not-blinded, randomization, Phase 1-2 on 240 patients. Block randomization will be used.
Settings and conduct
the location of the study will be at Ayatollah Moosavi in Zanjan city. the intevention group will take fentanyle through nebulizer for five minutes. the control group will take intravenous Morphine Sulfate for one minute. in both groups, patients will be observed in terms of pain severity as the main monitored outcome and under cardiac monitoring, pulse oximetry , consistent control of respiratory rate, pulse rate , and the level of consciousness and the results will be recorded in the fifth, tenth, fifteenth, thirtieth and sixtieth minute. in case of nonresponsiveness to treatment in the fifteenth minute , the saving dose of intravenous Morphine Sulfate at fifteenth and thirtieth minutes.
Participants/Inclusion and exclusion criteria
inclusion criteria:
all patients referring to emergency with a complaint of pain of acute trauma of limb with pain severity more than 5 based on 10-digit scale
age between 20 to 50 years
exclusion criteria:
pregnancy and lactation , patients with multiple myeloma , patients with respiratory disorders like asthma ..., patients under treatment with neurological medications , drug and alcohol addiction , patient with chronic pain and long time consumption of analgesic medications
Intervention groups
the intervention group will take nebulizer of fentanyl during five minutes
Main outcome variables
pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191109045385N1
Registration date:2020-05-20, 1399/02/31
Registration timing:retrospective
Last update:2020-05-20, 1399/02/31
Update count:0
Registration date
2020-05-20, 1399/02/31
Registrant information
Name
Sarvenaz Salahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4424 2647
Email address
salahi13639@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the comparison of the effect of nebulizer of fentanyl and intravenous morphine in controlling the pain of patients with fracture of long bone
Public title
the comparison of pain controlling effect of nebulizer of fentanyl and intravenous morphine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients aged 20-50 years
Referring to emergency department
the complaint of pain of acute trauma of limb
the pain severity more than 5 based on 10-digit scale of pain
Exclusion criteria:
Age
From 20 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization using a table of random numbers. Each of the eligible persons is given a numeric code. Then, each number selected by the computer is placed in the intervention group. After selecting 120 individuals as the intervention group, the remaining individuals are considered as the control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of medical sciences
Street address
Zanjan province, Zanjan, Gavazang Boulevard
City
Zanjan
Province
Zanjan
Postal code
4513956183
Approval date
2019-06-21, 1398/03/31
Ethics committee reference number
IR.ZUMS.REC.1398.072
Health conditions studied
1
Description of health condition studied
fracture of long bone
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma
Primary outcomes
1
Description
pain severity
Timepoint
at the fifth, tenth , fifteenth , thirtieth and sixtieth minute after starting consumption of nebulizer of fentanyl in intervention group and consumption of intravenous Morphine Sulfate
Method of measurement
10-digit apin scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: will take the nebulizer of fentanyl during five minutes
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Moosavi hospital
Full name of responsible person
غلامرضا حمیدخلق
Street address
Zanjan province , Zanjan , Gavazang Boulevard
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
salahi13639@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohsen Salehi
Street address
Zanjan province, Zanjan, Gavazang Boulevard
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
Mousavihospital@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohsen Salehi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Zanjan province , Zanjan, Gavazang Boulevard
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
m.salehi@zums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mohsen Salehi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Zanjan province , Zanjan, Gavazang Boulevard
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
m.salehi@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
غلامرضا حمید خلق
Position
رزیدنت
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Zanjan province , Zanjan, Gavazang Boulevard
City
Zanjan
Province
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Email
Hamidkholgh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
there is no other information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available