Protocol summary

Summary
Objective Comparison between intravenous morphine versus fentanyl efficacy in acute pain relief in drug abuser patients with pain due to acute limb traumatic injury Inclusion criteria All patients with traumatic limb pain who are above 18 and have history of opioid addiction enrolled in the study. Exclusion criteria Patients with decreased level of consciousness and history of opioid drug consumption after traumatic injury excluded from the study study population All traumatic limb patients who come to the emergency department of Sina and Shariati Hospital during the study period Sample size Calculated sample size is 320 patients in both group of the study, 160 cases and 160 control patients Interventions and primary outcome This randomized double blind study will conduct in emergency departments of Shariati and Sina Hospitals of Tehran.After signing of informed consent form and explaining the nature of study should determine their pain level score according to VAS. Then patients randomly assigned to each group of study. Group A receive intravenous morphine sulfate 0.1 mg/kg (morphine 10 mg/cc, Daru Pakhsh, Tehran, Iran) and group b receive fentanyl hydro-chloride 1 µg/kg(fentanyl, 500µg/10cc, abureyhan, Tehran, Iran). Vas score should checked before drug administration and 5, 15, 30, and 60 min after drug administration in both groups. In both group of the study if pain level reduced less than 13 mm after drug administration( morphine or fentanyl) in 5 min after drug administration the rescue dose should be considered.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201601308872N10
Registration date: 2016-02-13, 1394/11/24
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-02-13, 1394/11/24
Registrant information
Name
Morteza Saeedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2719
Email address
m_saeedi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
deputy of research of Tehran University of Medical Sciences
Expected recruitment start date
2016-02-22, 1394/12/03
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between intravenous morphine versus fentanyl efficacy in acute pain relief in drug abuser patients with pain due to acute limb traumatic injury
Public title
Effectiveness of intravenous fentanyl in opioid user patients with limb trauma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age above 18; limb injury;Glasgow coma scale above 14; pain intensity above 5 cm according to visual analogue scale(VAS); past history of opioid usage and history of usage in last week; hemodynamic stability. Exclusion criteria: decrease level of consciousness during drug injection; history of chronic illness( asthma, congenital or acquired heart disease, chronic liver disease, billiary disease, chronic kidney and lung disease); allergy to fentanyl and morphine; lack of cooperation in study process; opioid consumption after acute limb traumatic injury
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 320
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Qods street, keshavarz Blvd
City
Tehran
Postal code
Approval date
2015-09-16, 1394/06/25
Ethics committee reference number
ir.tums.rec.1394.781

Health conditions studied

1

Description of health condition studied
Injury, poisoning and certain other consequences of external causes
ICD-10 code
T10,T11,T1
ICD-10 code description
Fracture of upper limb, level unspecified, Other injuries of upper limb, level unspecified, Fracture of lower limb, level unspecified, Other injuries of lower limb, level unspecified

Primary outcomes

1

Description
pain level of patients
Timepoint
0,5,15,30,60
Method of measurement
visual analoge scale

Secondary outcomes

1

Description
drug complications
Timepoint
After drud prescription
Method of measurement
ABSEVATION AND PATIENT COMPLAIN

2

Description
Patient satisfaction
Timepoint
After pain control
Method of measurement
beck questionary

Intervention groups

1

Description
Intervention group (B) receive 1 micro/kg intravenous fentanyl
Category
Treatment - Drugs

2

Description
Group A receive intravenous morphine sulfate 0.1 mg/kg
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Hojat Sheikhmotahar Vahedi
Street address
City
Tehran

2

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Hojat Sheikhmotahar Vahedi
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh Basti
Street address
Building No 1, North entrance door of Tehran University, Poursina sreet, Qods street, Enghelab street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hojat Sheikh Motahar Vahedi
Position
Assistant professor/ Emergency Medicine specialist
Other areas of specialty/work
Street address
Shariati Hospital, North Amirabad street
City
Tehran
Postal code
Phone
+98 21 8490 2719
Fax
Email
vahedihojat@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hojat Sheikh Motahar Vahedi
Position
Assistant professor/ Emergency Medicine specialist
Other areas of specialty/work
Street address
Shariati Hospital, North Amirabad street
City
Tehran
Postal code
Phone
+98 21 8490 2719
Fax
Email
vahedihijat@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Morteza Saeedi
Position
Associate professor/ Emergency Medicine specialist
Other areas of specialty/work
Street address
Shariati Hospital, North Amirabad street
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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