1. Home
  2. Approved trials
  3. » فارسی

Comparison the analgesic effect of nebulized fentanyl and infusion of ketamine for pain management of long bone fractures

Protocol summary

Summary
The aim of present study is comparing the analgesic effect of ketamine infusion with nebulized fentanyl for control of pain in patients with long bone fractures in a double-blind randomized clinical trial, in participants admitted to the emergency department of Imam Khomeini and Golestan hospital of Ahvaz in 2016-2017. Inclusion criteria: age 18 to 55 years, exclusion criteria: passing more than 24 hours of fractures, fractures avulsion, head injury, a history of smoking or drug abuse, pregnancy and lactation, signs of alcohol drinking or consumption, loss of consciousness, difficulty in breathing, allergy to ketamine, and a history of seizures. After obtaining consent, eligible patients will be divided randomly into two groups (each group 68). For first group 5 mL of saline intravenously and 4 mg/kg of solution, 50 micrograms per ml of fentanyl that its volume with normal saline arrives to 5 cc, receive with nebulizer and for the second group 0.4 mg/kg ketamine will be infused within 10 minutes. Pain intensity will be recorded by visual pain scale (VAS) before and (5, 10, 15, 30 and 60 minutes) after intervention. If pain is not controlled or sustained after interventions, additional painkiller will be prescribed and information will be recorded. Finally, medication side effects (nausea, vomiting, hallucinations, difficulty breathing and drowsiness) will be evaluated in patients.

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2017031229801N2
Registration date: 2017-06-17, 1396/03/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-06-17, 1396/03/27
Registrant information
Name
Saeid Sadeghiyan
Name of organization / entity
Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 937 134 4848
Email address
b_sadeghian@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research Of Ahvaz Jundishapur University Of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the analgesic effect of nebulized fentanyl and infusion of ketamine for pain management of long bone fractures
Public title
Comparison the analgesic effect of nebulized fentanyl and infusion of ketamine for pain management in patients with long bone fractures in a clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 18 to 55 years Exclusion criteria: passing more than 24 hours of fractures; Avulsion fractures; head injury (if the level of consciousness decreased ); a history of smoking or drug abuse; pregnancy and lactation; signs of alcohol ( alcoholic patients ); loss of consciousness; difficulty in breathing; allergy to ketamine; a history of seizures
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 136
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In this study will be used a block randomisation method for randomisation.

Secondary Ids

1

Registry name
-
Secondary trial Id
-
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur Of Medical Sciences
Street address
Golestan Street, Vice Chancellor For Research Of Ahvaz Jundishapur University Of Medical Sciences, University Town, Ahvaz
City
Ahvaz
Postal code
15794 – 61357
Approval date
2016-11-19, 1395/08/29
Ethics committee reference number
IR.AJUMS.REC. 1395 .553

Health conditions studied

1

Description of health condition studied
Long bone fractures
ICD-10 code
M84
ICD-10 code description
Disorders of continuity of bone

Primary outcomes

1

Description
Pain
Timepoint
Before the intervention, and (5, 10, 15, 30 and 60 minutes) after intervention
Method of measurement
Visual pain scale

Secondary outcomes

1

Description
Medication side effects
Timepoint
(5, 10, 15, 30 and 60 ) minutes after intervention
Method of measurement
vital signs monitoring and symptoms created after the intervention.

Intervention groups

1

Description
Intervention group: For first group 5 mL of saline intravenously and 4 micrograms per kilogram of solution, 50 micrograms per ml of fentanyl that its volume with normal saline arrives to 5 cc, receive with nebulizer within 10 minutes.
Category
Treatment - Drugs

2

Description
Intervention group: for the second group 0.4 mg/kg ketamine within 10 minutes will be infused.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Doctor Afsaneh khazaeli, Resident
Street address
24 Metry, Department of Emergency Medicine, Imam khomeni Hospital, Ahvaz
City
Ahvaz

2

Recruitment center
Name of recruitment center
Golestan Hospital
Full name of responsible person
Doctor Afsaneh khazaeli, Resident
Street address
Golestan Street, Department Of Emergency Medicine, Golestan Hospital, Ahvaz
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor For Research Of Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Dr Behzad Sharif Zadeh
Street address
Golestan Street, Vice Chancellor For Research Of Ahvaz Jundishapur University Of Medical Sciences, University Town, Ahvaz
City
Ahvaz
Grant name
-
Grant code / Reference number
- -
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research Of Ahvaz Jundishapur 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
Department of Emergency Medicine
Full name of responsible person
Dr Afsaneh khazaeli
Position
Resident
Other areas of specialty/work
Street address
Golestan Street, Department Of Emergency Medicine, Golestan Hospital, Ahvaz
City
Ahvaz
Postal code
-
Phone
+98 61 3338 1581
Fax
-
Email
A65khazaeli@gmail.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University Of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Malaki varaki
Position
MD, Emergency Medicine Specialist, Assistant Professor
Other areas of specialty/work
Street address
Golestan Street, Emergency Medicine Department, Golestan Hospital, Ahvaz
City
Ahvaz
Postal code
-
Phone
+98 61 3374 3099
Fax
-
Email
Drmalaki676@yahoo.com
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jondi Shapour University of Medical Sciences, Faculty Of Medicine
Full name of responsible person
Saeid Sadeghiyan
Position
Medical Intern
Other areas of specialty/work
Street address
Kianpars Street ,Martyr Rajai Dorm, Ahvaz
City
Ahvaz
Postal code
61559345563
Phone
-
Fax
-
Email
s.saeid92@gmail.com
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
Loading...