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The comparison effect of intravenous fentanyl with low dose ketamine on pain relief in methadone user patients with limb fracture

Protocol summary

Study aim
The comparison effect of intravenous fentanyl with low dose ketamine on pain relief in methadone user patients with a limb fracture
Design
A clinical trial without a parallel control group, single-blind, randomized
Settings and conduct
The trial will be conducted on 100 patients at Al-Zahra and Kashani hospitals. In advance, the two drugs will be prepared by an emergency medicine specialist and will be identified in packages coded A and B so that the prescriber, as well as the clinical and baseline patient record holder, is not aware of the type of intervention. Fentanyl and ketamine are used as single doses, with doses of 1-2 µg / kg and 0.3 mg/kg, respectively. Ketamine 0.3 mg/kg will be diluted with 100 ml of normal saline and administered intravenously and slowly for 15 minutes. Demographic data, disease history, vital signs, type of limb fracture, pain score of patients prior to drug administration (at baseline), and at 15, 30 and 60 minutes after drug administration. Possible side effects such as nausea, vomiting, loss of consciousness, hypoxia, hypotension, etc. will be recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Methadone users with limb fractures; Ages 18 to 65 years; Insensitivity to fentanyl and ketamine; Maxillofacial failure; No pregnancy; Lack of severe head trauma and decreased level of consciousness; No serious trauma to the chest and abdomen; Instability in terms of vital signs; No use of psychotropic drugs; No history of neuropsychiatric disorders; Consent to participate in this stud; Exclusion criteria: Severe hypoxia
Intervention groups
We have two intervention groups. One group received fentanyl and the other group received ketamine.
Main outcome variables
Pain score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171030037093N25
Registration date: 2019-12-04, 1398/09/13
Registration timing: registered_while_recruiting

Last update: 2019-12-04, 1398/09/13
Update count: 0
Registration date
2019-12-04, 1398/09/13
Registrant information
Name
Sadra Ansaripour
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3650 3487
Email address
st_ansari.s@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-11, 1398/06/20
Expected recruitment end date
2020-03-10, 1398/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison effect of intravenous fentanyl with low dose ketamine on pain relief in methadone user patients with limb fracture
Public title
The effect of fentanyl with ketamine on pain relief of methadone users
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Methadone users with limb fractures Ages 18 to 65 years Insensitivity to fentanyl and ketamine Maxillofacial failure No pregnancy Lack of severe head trauma and decreased level of consciousness No serious trauma to the chest and abdomen Instability in terms of vital signs No use of psychotropic drugs No history of neuropsychiatric disorders Consent to participate in this study.
Exclusion criteria:
Severe hypoxia
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Investigator
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
The study sample was simple randomly divided into two groups of 20 people, each by selective envelopes. Thus, each envelope containing one of the two A and B labels represented one of the groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In advance, the two drugs will be prepared by an emergency medicine specialist and will be identified in packages with codes A and B so that the prescriber is not aware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahn University of Medical Sciences, Hezar jarib st, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2019-05-12, 1398/02/22
Ethics committee reference number
IR.MUI.MED.REC.1398.043

Health conditions studied

1

Description of health condition studied
limb fracture
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain score
Timepoint
Before drug administration (at baseline), and at 15, 30 and 60 minutes after drug administration
Method of measurement
Based on Visual analog score from 0 to 10

Secondary outcomes

empty

Intervention groups

1

Description
First intervention group: receives Fentanyl ampoules made by Aburaihan pharmaceutical Co. 1-2 mg/kg as single dose intravenously and slowly for 15 minutes.
Category
Treatment - Drugs

2

Description
Second intervention group: receives Ketamine ampoules made by Aburaihan pharmaceutical Co 0.3 mg/kg diluted with 100 ml normal saline and administered as single dose, intravenously and slowly for 15 minutes.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-zahra hospital
Full name of responsible person
Mohsen Farghani
Street address
Sofe Blvd, Isfahan Province, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3669 0021
Email
dr.forghani514@yahoo.com

2

Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Mohsen Farghani
Street address
Kashani Street, Isfahan Province, Isfahan
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3669 0021
Email
dr.forghani514@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Isfahan University of Medical Sciences, Hezarjarib Avne
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
+98 31 3668 0048
Email
Farajzadegan@med.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
Mohsen Farghani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Negin Complex, Negin Stand, Kui No. 7, Zahid Ave., Taleghani Ave.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
36690021
Email
dr.forghani514@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohsen Farghani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Negin Complex, Negin Stand, Kui No. 7, Zahid Ave., Taleghani Ave.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
36690021
Email
dr.forghani514@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohsen Farghani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Emergency Medicine
Street address
Negin Complex, Negin Stand, Kui No. 7, Zahid Ave., Taleghani Ave.
City
Isfahan
Province
Isfehan
Postal code
7346181746
Phone
36690021
Email
dr.forghani514@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Information about the main outcome can be shared.
When the data will become available and for how long
Start the access period 4 months after publishing the results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Use data to complete clinical trial studies
From where data/document is obtainable
Al-Zahra Hospital and Kashani Hospital
What processes are involved for a request to access data/document
After the investigation of researcher request and presentation of required documents will be accessible.
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