Protocol summary

Summary
This is a double-blinded placebo-controlled interventional study that will performed in emergency department of a teaching hospital. All patients with traumatic hand fingers injuries who needed digital nerve block and older than 15 years will enter the study. Exclusion criteria are pregnancy, allergy to Ketamine or Lidocaine, communication problem and serious cardiovascular problems. Initial pain will be evaluated by Visual Analogue Scale. Patients will be randomly divided to two groups; Intervention group that receives 1cc of Ketamine and control group that receives 1cc of distilled water. The fluid will drop on one of nostrils of patients. 5 minutes later pain will be evaluated again and digital nerve block will be done as an standard and routine manner. The procedure will be performed after 5 minutes. Pain of block and procedure will be evaluated by VAS. Blood pressure and pulse rate will be measured before and right after 30 min after the procedure. Patients will be observed for half an hour for complications of Ketamine such as hallucination, nausea, vomiting, cough and other complications.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201206289162N3
Registration date: 2013-04-21, 1392/02/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-04-21, 1392/02/01
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
The project presented as a final thesis of one of the residents of emergency medicine educational group at Tehran University of Medical Sciences
Expected recruitment start date
2011-01-01, 1389/10/11
Expected recruitment end date
2011-10-30, 1390/08/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double-blinded placebo-control study of intranasal ketamin effects and complications in digital nerve block in traumatic hand injuries
Public title
The effect of intranasal Ketamine on digital nerve block pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Hand fingers trauma needed to digital nerve block for procedures; patients who signed the consent form Exclusion criteria: Age under 15; Can not communicate because of mental retardation; language barriers, loss of consciousness, intoxication or other causes; Pregnancy; Hemodynamic instability (systolic BP less than 90 or more than 180 mmHg); Chronic opium user or use any of sedative-analgesic in last 12 hours; Known reactive or anatomic airway diseases; Decompensated heart failure or acute coronary syndrome (based on History and physical exam OR documentations) ; Known allergy to Ketamine or Lidocaine.
Age
From 15 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 0
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
Ethics committee of research, Tehran University of Medical Sciences
Street address
6th floor, Central building, Qods Avenue, Keshavarz blvd
City
Tehran
Postal code
Approval date
2012-11-10, 1391/08/20
Ethics committee reference number
1935/130/D/91

Health conditions studied

1

Description of health condition studied
Local Anesthesia of Digital Nerve
ICD-10 code
Y48.3
ICD-10 code description
Local anaesthetics

Primary outcomes

1

Description
Pain of injured finger
Timepoint
entrance, after instillation of drug or placebo (pre-procedural pain), after completion of procedure (post-procedure pain)
Method of measurement
Numeric Rating Scale (NRS) 10 part

2

Description
Complication of control or placebo drug
Timepoint
continouesly from initial instillation of drug until 30 min after procedure
Method of measurement
Ketamine complication such as Hallucination, Nausea, vomiting, hypertension, agitation and seizure

Secondary outcomes

1

Description
Heart Rate
Timepoint
Before instilation and 30 min after that
Method of measurement
By pulse-oxymeter or Cardiac monitor

2

Description
Systolic BP
Timepoint
Before instilation and 30 min after that
Method of measurement
Sphygmomanometer

3

Description
Arterial O2 Saturation
Timepoint
Before instilation and 30 min after that
Method of measurement
By pulse-oxymeter

4

Description
Procedure complication
Timepoint
Begining of procedure until 30 min after that
Method of measurement
Hematoma, Bleeding, Ischemia, ...

Intervention groups

1

Description
Control group: 2 cc identical syringes contain 1cc Ketamine(=50mg) or 1cc distilled water prepared out of emergency department in blocks of 12. In control group 1 cc of distilled water will drop in one of nostrils of patients and ask them to hold their breath as could as possible and do not cough. All patients will observe for another 30 minutes for probable complications.
Category
Placebo

2

Description
Intervention group: 2 cc identical syringes contain 1cc Ketamine(=50mg) or 1cc distilled water prepared out of emergency department in blocks of 12. In intervention group 1 cc of Ketamine (=50 mg) will drop in one of nostrils of patients and ask them to hold their breath as could as possible and do not cough. All patients will observe for another 30 minutes for probable complications.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emergency department, Imam khomeini complex medicalcenter
Full name of responsible person
Amir Nejati M.D.
Street address
Emergency Department, Imam Khomeini hospital, Bagherkhan street, Tohid square
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akhondzadeh, Deputy of research, Medical School
Street address
Medical School, Poorsina Avenue, 16 Azar, Keshavarz Blvd, Tehran
City
Tehran
Grant name
Grant code / Reference number
Student thesis grant
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Amir Nejati M.D.
Position
Assistant Professor, Faculty of educational group of Emergency Medicine
Other areas of specialty/work
Street address
Emergency Department, Imam Hospital, Bagherkhan street, Tohid square
City
Tehran
Postal code
1439633761
Phone
+98 21 6119 2240
Fax
+98 21 6690 4848
Email
anejati@tums.ac.ir, nejati.am@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Nejati M.D.
Position
Assistant Professor, Faculty of educational group of Emergency Medicine
Other areas of specialty/work
Street address
Emergency Department, Imam Khomeini Hospital, Bagherkhan Street, Tohid square,
City
Tehran
Postal code
1439633761
Phone
+98 21 6119 2240
Fax
+98 21 6690 4848
Email
anejati@tums.ac.ir, nejati.am@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Amir Nejati M.D.
Position
Assistant Professor, Faculty of emergency medicine educational group
Other areas of specialty/work
Street address
Emergency Department, Imam Khomeini Hospital, Baqerkhan street, Tohid Square
City
Tehran
Postal code
1439633761
Phone
+98 21 6119 2240
Fax
+98 21 6690 4848
Email
anejati@tums.ac.ir, nejati.amir@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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