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Evaluation of the effect of Penthrox spray as an analgesic compared to Morphine in patients with upper or lower limb fracture: A clinical trial study

Protocol summary

Study aim
Determining the effectiveness of Pentrox spray as an analgesic in upper or lower limb fractures pain in the emergency room.
Design
A trpile-blinded randomized phase 3 clinical trial with parallel groups
Settings and conduct
This study will be conducted in the emergency department of Al-Zahra and Kashani Hospital in Isfahan, Iran, on 25 patients. The patients will be treated with the drug packages predetermined by the study supervisor (supervisor). The drug packages are completely similar in terms of shape, and the patient and the investigator are not aware of the contents of the packages. Forms are completed by the investigator, who is not aware of the contents of the packages. In the data analysis stage, the analysis will be done by the project advisor and the investigator, who are not aware of the contents of the drug packages, and only the patient group (group 1 or 2) will be used for data analysis.
Participants/Inclusion and exclusion criteria
Patients with upper or lower limb fracture who hemodynamically unstable and those who hadn't informed consent
Intervention groups
Methoxyflurane is a fluorinated hydrocarbon inhalation agent available in 3 cc ampoules used in the Pentorax inhaler as an intervention. To administer methoxyflurane, we use a Pentorax inhaler with activated charcoal. The patient is asked to cover the diluting valve with his finger, place the inhaler mouthpiece in his mouth, and exhale through the mouthpiece or nose. Each patient is prescribed a maximum of 1 ampoule, equivalent to 3 ccs without supplemental oxygen. Morphine is an opioid pain reliever injected intravenously at 0.1 mg per kilogram of weight as an infusion for the control group. Every time intravenous morphine is used, the vital signs, including pulse, heart rate, temperature, and Oxygen saturation percentage, Are recorded.
Main outcome variables
Determining mean pain in trauma patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230302057587N1
Registration date: 2023-04-17, 1402/01/28
Registration timing: prospective

Last update: 2023-04-17, 1402/01/28
Update count: 0
Registration date
2023-04-17, 1402/01/28
Registrant information
Name
mohammad golban
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3435 3008
Email address
mohammad_golban@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Penthrox spray as an analgesic compared to Morphine in patients with upper or lower limb fracture: A clinical trial study
Public title
Analgesic effect of Penthrox spray in patients with upper or lower limb fracture
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with upper or lower fracture Age between 20 to 55 Informed consent to participation in the study
Exclusion criteria:
Impaired level of consciousness (Glasgow coma score less than 15) Hemodynamic disturbance during use (systolic blood pressure less than 90 mmHg, peripheral rate less than 60 beats per minute, breathing rate less than 8 per minute, blood oxygen saturation less than 90% Use of substances, alcohol, sedatives or pain relievers in the past 48 hours History of taking Monoamine Oxidase Inhibitors, Tricyclic Antidepressants, Serotonin Receptors Reuptake Inhibitors, Phenothiazines, and sleeping pills Suffering from chronic diseases such as congenital or acquired heart diseases, chronic liver failure, bile duct diseases, kidney failure and chronic lung disease according to history and clinical examination. Allergy to Morphine or Penthrox Weight more than 100 kg Lack of informed consent Patient non-cooperation
Age
From 20 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 25
Randomization (investigator's opinion)
Randomized
Randomization description
Using Permuted block randomization method, patients are placed in one of the two study groups and receive the intervention related to the same group.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The participants, the principal investigator, the health care personnel (doctors, nurses, physiotherapists, etc.) responsible for the patient's care, the consultant professor, and the analyst were blinded.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Isfahan University of Medical Sciences
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2020-03-30, 1399/01/11
Ethics committee reference number
IR.MUI.MED.REC.1399.014

Health conditions studied

1

Description of health condition studied
Analgesics
ICD-10 code
Y45.0
ICD-10 code description
Opioids and related analgesics

Primary outcomes

1

Description
Pain number in the Visual Analogue Scale (VAS)
Timepoint
10, 20, 30, 60 minutes after receiving the medicine
Method of measurement
The Visual Analogue Scale (VAS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Methoxyflurane, a fluorinated hydrocarbon inhalation agent available in 3 cc ampoules, used in the Pentorax inhaler (manufactured by MDI, Melbourne, Australia). Three cc of methoxyflurane are poured into each spray. If the diluting valve is open, the spray emits 0.2-0.4%, and if it is closed, it releases 0.5-0.7% methoxyflurane. It also has an oxygen port. To administer methoxyflurane, we use a Pentorax inhaler with activated charcoal. The patient is asked to cover the diluting valve with his finger and put the nebulizer mouthpiece in his mouth, and exhale through the mouthpiece or nose. A maximum of 1 vial (equivalent to 3 ccs) is prescribed to each patient without supplemental oxygen. Each care provider administers methoxyflurane to two patients in his shift. Each inhaler is used only for one patient. Vital signs, including pulse rate, heart rate, oxygen saturation percentage, and body temperature, are recorded in each inhalation of Penthrox. All patients undergo cardiac monitoring, and if changes are made, they are recorded with an electrocardiogram. Any side effects caused by the drug, including hypotension, bradycardia, convulsions, decreased level of consciousness, itching, skin rash, and respiratory depression, are recorded. Every ten minutes, if the patient's pain level is 5.10, intravenous fentanyl with a dose of 1 microgram per kilogram of weight will be prescribed as a rescue dose. At the end of the meeting, the rescue dose of fentanyl will be recorded.
Category
Treatment - Drugs

2

Description
Control group: Intravenous morphine at a dose of 0.1 mg per kilogram of weight (manufactured by Daro Pakhsh Co., Tehran, Iran) will be infused. Every time the intravenous morphine is used, the vital signs including pulse rate, heart rate, degree of temperature and percentage of oxygen saturation are recorded. All patients undergo cardiac monitoring, and if changes are made, they are recorded with an electrocardiogram. Any side effects caused by the drug, including hypotension, bradycardia, convulsions, decreased level of consciousness, itching, skin rash, and respiratory depression are recorded. Every ten minutes, if the patient's pain level is 5.10, intravenous fentanyl with a dose of 1 microgram per kilogram of weight will be prescribed as a rescue dose, and at the end of the meeting, the rescue dose of fentanyl will be recorded.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Dr. Seyed Mohammad Reza Safavi
Street address
Safeh Street, Al-Zahra Medical Education Center, Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-75731
Phone
+98 31 3620 2020
Email
Alzahra@mui.ac.ir

2

Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital
Full name of responsible person
Dr. Mojtaba Rahimi
Street address
Kashani St
City
Isfahan
Province
Isfehan
Postal code
81746-75731
Phone
+98 31 3233 0091
Email
AyatollahKashani@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Hazar jarib St., Isfahan University of Medical Sciences and Health Care Services
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Gulban
Position
Residence
Latest degree
Medical doctor
Other areas of specialty/work
Emergency Medicine
Street address
Hazar Jarib St., Isfahan University of Medical Sciences and Health Care Services
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 7898
Email
mohammad_golban@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Azizkhani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Ehsan Complex, Shkoufeh Alley, Gulkhane St., Khane Isfahan
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3620 2085
Email
Azizkhani.reza@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad Golban
Position
Specialist
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
B161, zeitoon complex, razmandegan blvd, robot st.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3435 3008
Fax
Email
mohammad_golban@yahoo.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 further 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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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