Objectives: Comparing the analgesia effect of morphine and morphine plus memantin in patients with lower limb trauma.
Inclusion Criteria: Fracture in lower extremity; GCS=15; VAS≥6 ; ability to talk; stable hemodynamic.
Exclusion Criteria: age>65 and age <18; Opium addiction; Psychological disorder; analgesia administration before admission in Emergency department; chronic therapy with analgesic drugs; sensitivity to morphine or memantin; unable to understand the VAS concept; pregnancy; necessity to nerve block; unwilling to take part in the intervention; refuse to continue the intervention; major trauma which is life threatening or causing defects; any history of chronic disease.
The population of study is included in patients suffering lower extremity fracture, who are admitted suffering severe pain(VAS≥6), requiring analgesia.
Sample of Study: According to population of study, 333 patients will be studied in each group.
Intervention of Study: Investigation of the analgesic effect of Memantin in patients suffering Limb Trauma.
Outcome: The effect on Pain Severity 0, 60, 120, 240, 480 and 720 minutes after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404107751N3
Registration date:2014-11-28, 1393/09/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-28, 1393/09/07
Registrant information
Name
Davood Farsi
Name of organization / entity
TUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 6652 5327
Email address
dfarsi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of analgesic effect of memantin plus morphin with morphin in patient with lower limb trauma
Public title
Pain control in Lower limb traumatic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Fracture in lower extremity; GCS=15; VAS≥6 ; ability to talk; stable hemodynamic. Exclusion Criteria: age>65 and age <18; Opium addiction; Psychological disorder; analgesia administration before admission in Emergency department; chronic therapy with analgesic drugs; sensitivity to morphine or memantin; unable to understand the VAS concept; pregnancy; necessity to nerve block; unwilling to take part in the intervention; refuse to continue the intervention; major trauma which is life threatening or causing defects; any history of chronic liver; kidney; lung; cardiac disease
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
1000
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
Iran University of Medical Sciences
Street address
Hemmat highway, next to Milad Hospital
City
Tehran
Postal code
Approval date
2014-04-26, 1393/02/06
Ethics committee reference number
93/د/105/373
Health conditions studied
1
Description of health condition studied
Pain in limb
ICD-10 code
M79.6
ICD-10 code description
Pain in limb
Primary outcomes
1
Description
Pain Severity
Timepoint
0, 60, 120, 240, 480 and 720 minutes after treatment
Method of measurement
Administration of Visual Analogue Scale and asking the patient to determine the severity of pain
Secondary outcomes
1
Description
Side effects and changes in vital signs
Timepoint
30, 60 and 120 minutes after treatment
Method of measurement
Patient monitoring
Intervention groups
1
Description
first group:morphin+memantin 10 mg
Category
Treatment - Drugs
2
Description
second group:morphin+memantin 5 mg
Category
Treatment - Drugs
3
Description
third group:morphin +placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emergency Department of Hazrate Rasool (S) Educational-Therapeutic Centre