A clinical trial to evaluate the effect of inhaled pharmaceutical Penthrox (Methoxyflurane) compared with the placebo group on pain in patients with limb fracture
Objectives: Following the accident, between emergency responders get to the patients and reach them to the hospital, there is a considerable time that most patients complain is pain during this interval. The aim of this study was to evaluate the analgesic effect of inhaled Penthrox as a treatment for injuries caused by the fracture.
METHODS: This study is performed at the Baqiyatallah University of medical sciences. This is a triple-blind randomized clinical trial. In this study, the patients, measuring the outcomes of study participants (researchers) or Data Monitoring Committee (analyzers) of the patients unaware about intervention. The study included 100 patients with limb fractures were transferred by ambulance to the emergency ward. Patients randomly using a table of random numbers in the two groups (each group 50 patients). Methoxyflurane inhalation drug in intervention group (Penthrox) and placebo in controls will be used. The main outcome of this study is the pain and assess using standard criteria (visual analog scale (VAS)). Duration of improves patients outcomes is another outcome in this study. This clinical trial is a phase 2 study.
Exclusion criteria are:
1. The history of allergies
2. History of liver disease
3. The history of kidney disease
4. Liver and kidney disease
6. Trauma and rupture of the liver and kidneys
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015111724799N3
Registration date:2015-12-09, 1394/09/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-09, 1394/09/18
Registrant information
Name
Masoud Saghafinia
Name of organization / entity
Baqiyatallah university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 3207
Email address
dr_saghafi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of medical sciences and Khosro Medisa Teb
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to evaluate the effect of inhaled pharmaceutical Penthrox (Methoxyflurane) compared with the placebo group on pain in patients with limb fracture
Public title
Effect of inhaled pharmaceutical Penthrox (Methoxyflurane) on pain of limb fracture
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patients older than 18 years who have had limb fractures.
Exclusion criteria: Patients with a history of allergy to inhaled medications, severe injuries, including a ruptured liver and the kidneys, liver disease, kidney disease, patient dissatisfaction and age under 18 and over 80 years as well as patients with a decreased level of consciousness
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple 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 Baqiyatallah University of Medical Sciences
Street address
Postal code: 1435917541, Mollasadra, St - Sheikh Bahaee, St, Tehran
City
Tehran
Postal code
1435917541
Approval date
2009-11-03, 1388/08/12
Ethics committee reference number
ir.bssu.rec.1388.7
Health conditions studied
1
Description of health condition studied
Sequelae of fracture of arm
ICD-10 code
T92.1
ICD-10 code description
Sequelae of injury classifiable to S42.-, S52.- and T10
2
Description of health condition studied
Sequelae of other fractures of lower limb
ICD-10 code
T93.2
ICD-10 code description
Sequelae of injury classifiable to S82.-, S92.- and T12
Primary outcomes
1
Description
Pain
Timepoint
Before intervention, 5, 10, 20 and 30 minutes after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Times of pain reduction
Timepoint
Before intervention, 5, 10, 20 and 30 minutes after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention 2: Placebo
Category
Placebo
2
Description
Intervention 1: Penthrox inhaler, the recommended dose is 6 milliliters, one time. It is manufactured and marketed by Medical Developments International (Melbourne, Victoria, Australia). Penthrox is known chemically as 2, 2–Dichloro-1, 1-Difluoroethyl methyl
Ether. Brand of Penthrox is Methoxyflurane.
How to use: A cylindrical whistle-like tube with a hole near the mouthpiece.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency department of Baqiyatallah university of medical sciences
Full name of responsible person
Masoud Saghafinia
Street address
Postal code: 1435917541, Mollasadra, St - Sheikh, St, Tehran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Baqiyatallah University of Medical Sciences
Full name of responsible person
Hamid Reza Rasouli
Street address
Postal code: 1435917541, Mollasadra, St - Sheikh Bahaee, St, Tehran
City
Tehran
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, Baqiyatallah 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
Baqiyatallah university of medical sciences
Full name of responsible person
Masoud Saghafinia
Position
Faculty member/Anesthesiologist
Other areas of specialty/work
Street address
Postal code: 1435917541, Mollasadra, St - Sheikh Bahaee, St, Tehran
City
Tehran
Postal code
Phone
+98 21 8805 3766
Fax
Email
dr_saghafi@bmsu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Baqiyatallah University of Medical Sciences
Full name of responsible person
Masoud Saghafinia
Position
Faculty member/Anesthesiologist
Other areas of specialty/work
Street address
Postal code: 1435917541, Mollasadra, St - Sheikh Bahaee, St, Tehran
City
Tehran
Postal code
Phone
+880 53766
Fax
Email
dr_saghafi@bmsu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Baqiyatallah university of medical sciences
Full name of responsible person
Masoud Saghafinia
Position
Faculty member/Anesthesiologist
Other areas of specialty/work
Street address
Postal code: 1435917541, Mollasadra, St - Sheikh Bahaee, St, Tehran
City
Tehran
Postal code
Phone
+98 21 8805 3766
Fax
Email
dr_saghafi@bmsu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)