Objectives: Comparison of analgesic effects and complication of intravenous low dose Ketamine versus intravenous Morphine
Design: In a prospective; single-site; double-blind randomized controlled trial phase 3, 606 patients aged between 15 to 55 years old with isolated lower or upper limb orthopedic injury who have visual analog score of pain more than 50 mm, enrolled to the study considering inclusion and exclusion criteria
Setting and conduct: The eligible patients will be simply randomized in two treatment groups by using of randomized numbers table. The sample size estimates 303 patients in each group based on Alpha 5% and 90% power and 20% as loss potential. Group A and B will be treated with intravenous Ketamine 0.25 mg/kg and intravenous Morphine 0.1 mg/kg respectively. Patients & investigators will be blind to groups of study.
Main outcome measures: The reduction in visual analog score of pain and complications at 0, 5th, 10th, 20th minute and need for rescue analgesia at 20th minute will be recorded and the difference between these values will be evaluated by statistical methods
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015122225660N1
Registration date:2016-02-28, 1394/12/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-28, 1394/12/09
Registrant information
Name
Ramin Parvizrad
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 863222003
Email address
r.parvizrad@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Arak University of Medical Sciences, Arak, Iran
Expected recruitment start date
2014-05-01, 1393/02/11
Expected recruitment end date
2014-12-30, 1393/10/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of analgesic effect of intravenous ketamine versus intravenous Morphine in isolated orthopedic trauma patients
Public title
analgesic effect of intravenous ketamine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with isolated trauma with fracture in the upper or lower extremities; aged between 15 and 55 years old; with Visual Analogue Scale pain score of more than 50 mm.
Exclusion criteria: Patient’s refusal to participate in the study; having an underlying medical condition such as migraine, cardiac ischemia, schizophrenia, history of allergy to opiates or ketamine, head trauma or loss of consciousness; blood pressure of more than 180/100; vital signs Instability before and during the study; pregnancy; any inability to express their pain during the study; presence of other trauma.
Age
From 15 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
606
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Drugs were labeled by a study investigator as A or B in prefilled syringes in which both drug diluted until 0.1 milliliter of each syringe serve desired dose of the agent. We used 0.1 mg/kg dosage for morphine and 0.25 mg/kg for ketamine group. The eligible patients will be simply randomized in two treatment groups by using of randomized numbers table. The medication was administered by intravenous infusion during 5 minutes by registered treating nurse in a blinded fashion
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
Approval date
2014-02-03, 1392/11/14
Ethics committee reference number
92-157-17
Health conditions studied
1
Description of health condition studied
Upper or Lower limb fracture
ICD-10 code
T10, T12
ICD-10 code description
Fracture of upper limb, level unspecified, Fracture of lower limb, level unspecified
2
Description of health condition studied
Upper or Lower limb dislocation
ICD-10 code
T11.2, T13
ICD-10 code description
Dislocation, sprain and strain of unspecified joint and ligament of upper limb or lower limb, level unspecified
Before intervention, 5, 10 and 20 minutes after intervention
Method of measurement
physical examination
2
Description
Need for rescue analgesia
Timepoint
20 minutes after intervention
Method of measurement
Visual analog scale of pain
Intervention groups
1
Description
Intervention1 (case group): In Group A, patients receive a dose of 0.25 mg / kg iv ketamine. Drugs’ dose are calculated based on patient weight. Pain severity base on visual analog score (VAS) and complication such as dizziness, nausea, amnesia, headache, will be recorded at 0th, 5th, 10th and 20th minute. In patients with VAS of pain more than 50 mm at 20th minute, 0.05 mg/kg of intravenous morphine will be administrated as rescue analgesia .
Category
Treatment - Drugs
2
Description
Intervention2 (case group): In Group B, patients receive a dose of 0.1 mg / kg iv morphine. Drugs’ dose are calculated based on patient weight. Pain severity base on visual analog score (VAS) and complication such as dizziness, nausea, pain, amnesia, headache, will be recorded at 0, 5th, 10th and 20th minute. In patients with VAS of pain more than 50 mm at 20th minute, 0.05 mg / kg of intravenous morphine will be administrated as rescue analgesia.