Comparison of oral oxycodone and intravenous acetaminophen with intravenous morphine sulfate for acute pain management in trauma patients admitted to the emergency department of rasool Hospital, Tehran
Pain management in traumatic patients is one of the main debates in the emergency department. Various medications have been prescribed for pain management in these patients. This study has been designed to compare two methods of pain relief in trauma patients with oral oxycodone and intravenous acetaminophen with intravenous morphine sulfate. In this trial, the study population are traumatic patients with pain score of 5 and more, who need pain relief and referred to emergency department of Rasool Akram hospital, Tehran during Jan 2012 and April 2012. Estimated sample size is 150 patients, who will be recruited in the study according to inclusion and exclusion criteria and will randomized in two group: oral oxycodone and intravenous acetaminophen(75 patients) and intravenous morphine sulfate (75 patients). Patients will evaluate by a physician during the study about pain severity and any complication. In this study, pain will be evaluated based on Visual Analog Scale before treatment, 10 minutes later, 30 minutes and 60 minutes after administration of drugs. Besides, the patient's vital signs and possible complications caused by the drugs will be evaluated and recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204298104N8
Registration date:2012-05-06, 1391/02/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-05-06, 1391/02/17
Registrant information
Name
Mohammad Amin Zare
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 5327
Email address
ma-zare@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of oral oxycodone and intravenous acetaminophen with intravenous morphine sulfate for acute pain management in trauma patients admitted to the emergency department of rasool Hospital, Tehran
Public title
Comparison of Oral oxycodone and intravenous acetaminophen with intravenous morphine sulfate for acute pain in trauma patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: signing informed consent by the participate in the study; age greater than 16 and less than 50 years old; moderate to severe pain caused by trauma (pain score above 5 on the visual Analog scale) and trauma to extremities without head trauma.
Exclusion criteria: history of allergy or intolerance to morphine sulphate or oxycodone; concurrent substance abuse; mild to moderate pain (pain score of less than 5); psychiatric disorders; patients with history of chronic obstructive pulmonary disease, asthma, and ischemic heart disease; reduction in the patient's level of consciousness (GCS score less than 15 ); patients with low blood pressure (systolic blood pressure less than 90 mmHg); patients with liver dysfunction and pneumothorax.
Age
From 16 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Sixth floor, Tehran University of Medical Sciences main bulding, Ghods street, Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
144574311
Approval date
2012-03-04, 1390/12/14
Ethics committee reference number
90/د/2478/130
Health conditions studied
1
Description of health condition studied
trauma
ICD-10 code
XIII
ICD-10 code description
musculoskeletal sysytem and connective tissue diseases
Primary outcomes
1
Description
Pain control
Timepoint
At the begining, 10, 30 and 60 minutes after the administration of the study medications
Method of measurement
Pain score by asking from patient
Secondary outcomes
1
Description
Side effects and changes in vital signs
Timepoint
At the begining, 10, 30 and 60 minutes after the administration of the study medications
Method of measurement
Monitoring the patients
Intervention groups
1
Description
Intervention group :administration of oxicodone 10mg/peroral and acetaminophen 1 gram intravenously and 5 cc streile waterintravenously as placebo and evaluation of pain score and side effects in minutes 0;10;30;60 of study.
Category
Treatment - Drugs
2
Description
Control Group: Administration of 5 mg Morphine sulfate and oral placebo, after 0, 10, 30, 60 minutes pain score and side effects will be evaluated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrate Rasool hospital
Full name of responsible person
Mohamad Amin Zare
Street address
Niyayesh street, Sattarkhan, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Shahin Akhondzadeh
Street address
Tehran University of Medical Sciences, Faculty of Medicine
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?