The comparison of analgesic effect of ketamine by per kg dose(0.75mg/kg) and fixed dose 50 mg on acute traumatic and non traumatic muscluskletal pain in patient come to Emegency ward of Emam khomeini hospital
The purpose of this study is comparing reduction of pain and complications of intranasal ketamine 0.75mg/kg versus fixed dose(50mg)of Ketamine in traumatic and non traumatic mucluskeletal pain. over 15 years old with acute musculoskeletal pain patients were enrolled and patients with hemodynamic instability, impaired level of consciousness, blood pressure above 180/110, increased intracranial pressure, headache, chest pain, abdominal pain were excluded.This study is a double blind randomized clinical trial and all patients with musculoskeletal pain in Emergency department of Imam Khomeini Hospital from July to March of 1391 were included. Sample size was 132 and participants were randomized into two intervention and control groups. In intervention group, divided by weight from 40 kg to 100 kg. intervention group received 0.75 mg/kg ketamine. control group received 50mg fixed dose of ketamine. We used numerical rating scale (NSR) for assessing reduction of pain every 10 minutes for one hour.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201212109162N5
Registration date:2014-02-03, 1392/11/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-03, 1392/11/14
Registrant information
Name
Amir Nejati
Name of organization / entity
Tehran University of Medical Sciences, Imam Khomeini Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2240
Email address
a-nejati@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
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of analgesic effect of ketamine by per kg dose(0.75mg/kg) and fixed dose 50 mg on acute traumatic and non traumatic muscluskletal pain in patient come to Emegency ward of Emam khomeini hospital
Public title
comparison the effect of ketamine by per kg dose and fixed dose on pain loss of traumatic and non traumatic injury
Purpose
Treatment
Inclusion/Exclusion criteria
structural disease of upper airway, age<15 yr, low LOC, dementia, unstable situation, patient request of analgesic, neck pain, headache, chest pain, rise in ICP, history of rise of Iop, person who take analgesic in last 24 hour, pregnant women, BP over 180/110, acute cronary disease, heart failure, ketamine sensitivity, nasal fracture & bleeding, use of opioid & analgesic in EMS or triage, recent nasopharynx and facial surgery, orbit & eye trauma, head trauma.
Age
From 15 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Deputy of Research- Tehran University of Medical Sciences
Street address
Keshavarz Blvd, Qods Avenue, Central Building of Tehran University of Medical Sciences
City
Tehran
Postal code
1439633764
Approval date
2012-09-02, 1391/06/12
Ethics committee reference number
9997/210/D/90
Health conditions studied
1
Description of health condition studied
trauma
ICD-10 code
S40-S49,S5
ICD-10 code description
Injuries to the shoulder and upper arm,Injuries to the elbow and forearm,Injuries to the wrist and handInjuries to the hip and thigh,Injuries to the knee and lower leg,Injuries to the knee and lower leg,Injuries to the ankle and foot,
Primary outcomes
1
Description
pain
Timepoint
10,20,30,40,60 min after injection drug
Method of measurement
numeric rating scale protocol
Secondary outcomes
empty
Intervention groups
1
Description
in control group ketamine injection 50 mg intra nasal
Category
Treatment - Drugs
2
Description
in intervention group injection of ketamin intranasal 0.75mg/kg