The primary objective of this study is to compare the pain level and side effects of nebulized morphine with intravenous morphine in trauma patients referred for musculoskeletal pain.
This study is a randomized clinical trial. Patients are not informed of the route of drug administration i.e. intravenous vs. nebulized.
Patients are randomized to receive morphine sulfate for pain relief via any of the 3 aforementioned methods (0.1 mg / kg intravenous morphine or 0.2 mg / kg of nebulized morphine or 0.4 mg / kg of nebulized morphine).
The Response to pain, and drug side effects are evaluated within designated time intervals of 0, 15, 30, and 45, 60-minute following the interventions by questionnaires.
Inclusion criteria:
Age: 18 and 65 years of age
Acute and severe musculoskeletal pain between 6 and 10 on VAS.
Exclusion criteria:
Disinclined to participate in research projects;
Drug addiction;
Systolic blood pressure less than 90 mm Hg;
GCS less than 15;
Pregnancy and lactation;
Known hypersensitivity to morphine and ketamine;
Need for local nerve block;
Incapable to understand the concept of VAS.
Sample size: We enrolled 240 patients.
We evaluated the response to pain relief, and the possible side effects of morphine in different dosage administered via intravenous vs. nebulized route in trauma patients with musculoskeletal pain.
The primary outcome: Pain relief
Secondary outcomes: Morphine side effects
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011431931N1
Registration date:2017-06-13, 1396/03/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-13, 1396/03/23
Registrant information
Name
Ali Dashti
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4462 6024
Email address
dashti.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-08-22, 1396/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the complications and pain relieving of nebulized morphine and intravenous morphine in trauma patients with musculoskeletal pain.
Public title
The effect of morphine in reducing pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were: age between 18 and 65 years; severe acute musculoskeletal pain between 6 and 10 on VAS. Exclusion criteria: Consent to participate in research projects; Drug addiction; Systolic blood pressure less than 90 mmHg; GCS less than 15; Heart, lung, kidney, liver or mental diseases; Pregnancy and lactation; Known hypersensitivity to morphine and ketamine.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences Besides Milad Tower, Hemmat Highway
City
Tehran
Postal code
Approval date
2015-11-15, 1394/08/24
Ethics committee reference number
IR.IUMS.REC 1395.9411307014
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
R52.0
ICD-10 code description
Acute pain
Primary outcomes
1
Description
Pain
Timepoint
0, 15 , 30, 45 and 60 minutes after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Hypotension
Timepoint
0, 15, 30, 45 and 60 minutes after intervention
Method of measurement
Blood pressure cuff
2
Description
Apnea
Timepoint
0 , 15, 30, 45 ,and 60 minutes after intervention
Method of measurement
puls oximetry
3
Description
Oxygen saturation
Timepoint
0 , 15, 30, 45 , and 60 minutes after intervention
Method of measurement
puls oximetry
4
Description
Nausea and vomiting
Timepoint
0 , 15, 30, 45 and 60 minutes after intervention
Method of measurement
Observation
Intervention groups
1
Description
Intervention group 1: 1.0 mg/kg of diluted morphine will be administered intravenously and 5 cc of sterile water will be given via nebulizer as placebo. Pain and drug side effects will be evaluated 0, 15, 30, 45, and 60-minute after drug administration and if the pain isn’t relieved, another 5 mg intravenous Morphine sulfate will be given.
Category
Treatment - Drugs
2
Description
Intervention group 2: 2.0 mg/kg of nebulized morphine sulfate is administered via facemask, and 5 cc of sterile water is given via nebulizer as placebo. Pain and drug side effects will be evaluated 0, 15, 30, 45, and 60-minute after drug administration and if the pain isn’t relieved, 5 mg intravenous Morphine sulfate will be given.
Category
Treatment - Drugs
3
Description
Intervention group 3: 4.0 mg/kg of nebulized morphine sulfate is administered via facemask and 5 cc of sterile water is given via nebulizer as placebo. Pain and drug side effects will be evaluated 0, 15, 30, 45, and 60-minute after drug administration and if the pain isn’t relieved, 5 mg intravenous Morphine sulfate will be given.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Dr.Mani mofidi, Dr.Ali Dashti
Street address
Rasoul Akram Hospital, Shahr Ara avenue, Niayesh avenue, Sattarkhan street
City
Tehran
2
Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Dr. Ali Dashti
Street address
Firoozgar Hospital,Valiasr blvd. Valiasr Sq. Tehran
City
Tehran
3
Recruitment center
Name of recruitment center
Hafte Tir Hospital
Full name of responsible person
Dr. Ali Dashti
Street address
Hafte Tir Hospital, Rajaie St. Shahre Rey. Tehran
City
Shahre Rey
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Research Assistant
Street address
Iran University of Medical Sciences, Besides Milad Tower, Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Ali Dashti
Position
Resident of Emergency Medicine
Other areas of specialty/work
Street address
Unit 5, Block 4 East, Second Floor, Rajai and Bahonar crossroad, South Shahin street, Tehran
City
Tehran
Postal code
Phone
+98 21 4462 6024
Fax
Email
Dr.Dashti82@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Mani Mofidi
Position
Associate Professor of Emergency Medicine
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Besides Milad Tower, Hemmat Highway
City
Tehran
Postal code
Phone
+98 912 226 3218
Fax
Email
Manimofidi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Dashti
Position
Resident of Emergency Medicine
Other areas of specialty/work
Street address
Unit 5, Block 4 East, Second Floor, Rajai and Bahonar crossroad, South Shahin street, Tehran
City
Tehran
Postal code
1473986466
Phone
+98 21 4462 6024
Fax
Email
Dr.Dashti82@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)