Comparison of Sedative Analgesic Effect of Nitrous Oxide versus Ketamine in limb fracture Pain Control , a Pilot Study.
Golestan hospital emergency ward
In a clinical trial study, the patients with limbs fracture who needed pain control were included in the intervention. The patients were studied in the Ahvaz Golestan Hospital General Hospital ED Department. The patients excluded from the study are those afflicted with chronic airway diseases and COPD subconscious patients with a history of reaction to NO or Ketamin a known case of psychiatric disease, patients afflicted with otitis media and patients who had food a liquids two hours before taking sedative dose. Patient over 18 years old referring to emergency ward will be randomly selected through computer random number generated method for use of one of the intravenous Ketamin or inhaled nitrous oxide. The mask is effective to the extent that the patients’ breath pressure is above 5 cm H2O or with the decrease of the breath pressure the mask breathing ceases. Ketamin receive 0.3 mg/kg intravenously. For each group, that patient’s amount of pain will be registered three times with an interval five minutes using VAS score setting. The results of 2 groups will be analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013111815446N1
Registration date:2014-05-29, 1393/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-29, 1393/03/08
Registrant information
Name
Hassan Motamed
Name of organization / entity
Emegency Department , Ahvaz Jundishapour University of Medical Sciences , Ahvaz , Iran
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3079
Email address
motamed-h@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2013-11-28, 1392/09/07
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Sedative Analgesic Effect of Nitrous Oxide versus Ketamine in limb fracture Pain Control , a Pilot Study.
Golestan hospital emergency ward
Public title
Comparison of Nitrous Oxided and Ketamin Sedative Analgesic Effect for Pain Control.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: any limbs fractures who are seeking for Pain Control.
Exclusion Criteria: COPD; liver disease; head injury; loss of consciousness; lung injury; asthma and patient disagreement.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ahvaz Jundishapur University of Medical Sciences
Street address
Esfand st., Golestaan st.
City
Ahvaz
Postal code
Approval date
2013-07-30, 1392/05/08
Ethics committee reference number
ajums.rec.1392.108
Health conditions studied
1
Description of health condition studied
Local anesthesia
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics
Primary outcomes
1
Description
Pain relief
Timepoint
Baseline, fifth, tenth, fifteenth minutes
Method of measurement
VAS score
Secondary outcomes
1
Description
Decrease blood pressure
Timepoint
Baseline, fifth, tenth, fifteenth minutes since start of drug give
Method of measurement
Patient monitoring- blood pressure measurement
2
Description
Respiratory faillue
Timepoint
Baseline, fifth, tenth, fifteenth minutes since start of drug give
Method of measurement
Patient monitoring- blood pressure measurement
3
Description
Vomiting
Timepoint
Baseline, fifth, tenth, fifteenth minutes since start of drug give
Method of measurement
Patient monitoring- blood pressure measurement
Intervention groups
1
Description
Intervention group: nitrous oxide 50:50 intake
Category
Treatment - Drugs
2
Description
Control group: recieve ketamin 0.3 mg/kg intravenus
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan hospital
Full name of responsible person
Dr. Hassan Motamed
Street address
Ahvaz Golestan hospital, Golestaan st.
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Nader Saki
Street address
Vice chancellor for research, Ahvaz University of Medical Sciences
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Hassan Motamed
Position
Emergency medicine assistant professor
Other areas of specialty/work
Street address
Golestan hospital
City
Ahvaz
Postal code
Phone
+98 61 1374 3079
Fax
Email
motamed-h@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Hassan Motamed
Position
Emergeny medicine assistant professor
Other areas of specialty/work
Street address
ahvaz golestan hospital
City
Ahvaz
Postal code
Phone
+98 61 1374 3079
Fax
Email
motamed-h@ajums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Hassan Motamed
Position
Emergency medicine assistant professor
Other areas of specialty/work
Street address
Golestaan hospital, Golestan st.
City
Ahvaaz
Postal code
Phone
+98 61 1374 3079
Fax
Email
motamed-h@ajums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)