Pain management is one of the most responsibilities of ED physician. Uncontrolled pain has very adverse effects such as patient suffering; sympathetic nerves stimulation and addiction to drugs in future. Aim of this study is finding a way to pain control faster; more efficient and with fewer complications and side effects. This study is a randomized; double blind; multicenters; clinical trial that patient with only trauma to limbs between 18 and 50 years old without head trauma and other diseases except present trauma and without adiction and drug consumptin before beginning of study randomizely divide by two groups. One group receive morphine 0.1 mg /kg +ketamine 0.2 mg/kg in minimum interval of 5 minutes with patient's request and other group receive morphine 0.1 mg/kg +0.02 ml/kg of sterile water as placebo in minimum interval of 5 minutes with patient's request. The major outcomes are pain controls and side effects that evaluate in 0,10,30,60,120 minute of study. The results will analyzed and compare between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112258104N4
Registration date:2012-04-27, 1391/02/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-27, 1391/02/08
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
2011-10-23, 1390/08/01
Expected recruitment end date
2012-01-01, 1390/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of intravenous morphine with morphine plus low dose of ketamine in trauma patients with severe pain
Public title
Pain control in trauma patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients above 18 years old with trauma only to limbs and severe pain (VAS equal or above 6). stable vital signs including systolic blood pressure equal or above 90 mm HG ; pulse rate between 60 and 120 per minute ; O2 saturation equal or above 90%; GCS =15 ; no addiction to drugs ;no consumption opioids or analgesics before begining of study ;no history of leaver diseases ;renal diseases; respiratory diseases ;cardiovascular diseases ; psychiatric diseases,blood diseases .
Exclusion criteria: history of head trauma and contraindications for ketamine or morphine administration ; allergy to morphine or ketamine ; need to regional nerve block ; unable to conception of VAS;no interest to participate in study
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
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
Ttehran University of Medical Sciences Ethics Committee
Street address
Ghods street- Keshavarz blvd- Tehran
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
21513/ 210 /د/90
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
0, 10, 30, 60, 90 and 120 minutes after treatment
Method of measurement
Visual Analogous Scale (VAS)
Secondary outcomes
1
Description
Side effects and changes in vital signs
Timepoint
30 and 60 minutes after treatment
Method of measurement
Patient monitoring
Intervention groups
1
Description
intervention group :administration of morphine 0.1 mg /kg +ketamine 0.2 mg/kg in minimum interval of 5 minutes with patient's request and evaluation of pain score and side effects in minutes 0;10;30;60;90;120 of study.
Category
Treatment - Drugs
2
Description
control group :administration of morphine 0.1 mg/kg +0.02 ml/kg of sterile water as placebo in minimum interval of 5 minutes with patient's request and evaluation of pain score and side effects in minutes 0;10;30;60;90;120 of study