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Assessment the effect of Clonidine and Dextromethorphan on cold pain threshold in healthy volunteers

Protocol summary

Summary
The goal of this study is to determine the threshold of pain from the cold after taking certain doses of Clonidine, Dextromethorphan and placebo. This study in third phase clinical trials, non random, double blind (Blind examiner and participant by coding pocket of drugs in secret by the supervisor), control with placebo, single central, cross-over, consists of 35 members of staff and students of Imam Khomeini hospital who volunteer picked through a public call on a hospital bulletin board. The main inclusion criteria are: physical and mental health, age 18-45 years and exclusion criteria are: pregnancy and any disease is affecting pain threshold. Evaluation of pain threshold in all stages will be base on the duration of time that a hand is kept in cold water. Participants are requested to immerse their hand in two liters of cold water and ice 0-2 °C and when they feel pain and they can't tolerate cold water, pull out their hand from water. All the pain thresholds of volunteers in 5 stages are measured: Before pharmacological interventions and after taking 0.2 mg Clonidine, 0.3 mg/kg Dextromethorphan, placebo, 0.2 mg Clonidine with 0.3 mg/kg Dextromethorphan and after necessary time to reach peak effect. Considering half lives of Clonidine and Dextromethorphan tablets and elimination the effects of drugs from body after 5 half-lives, wash out period and intervals of tablets taking and the measurement of pain thresholds is 10 days. Pharmacological interventions will be same for all volunteers in each stage.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016020826447N1
Registration date: 2016-05-12, 1395/02/23
Registration timing: na

Last update:
Update count: 0
Registration date
2016-05-12, 1395/02/23
Registrant information
Name
Amirhossein Orandi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2828
Email address
horandi@sina.tums.ac.ir
Recruitment status
Not enough for processing
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-05-14, 1395/02/25
Expected recruitment end date
empty
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effect of Clonidine and Dextromethorphan on cold pain threshold in healthy volunteers
Public title
The effect of Clonidine and Dextromethorphan on cold pain threshold
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: Complete physical and mental health; Informed consent to participate in the study; 18-45 years of age; No cigarette smoking and coffee use; No history of taking anti depressant and analgesic medications. Exclusion Criteria: Acute or chronic pain; Pregnancy; Gastrointestinal bleeding; Renal or liver disease; Asthma; Diabetes; Hyper tension; Mental and, or neurological disease; Hyper sensitivity to Clonidine and Dextromethorphan.
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 35
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, the corner of Qods St, Keshvarz Blvd, Tehran
City
Tehran
Postal code
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
IR.TUMS.REC.1394.2127

Health conditions studied

1

Description of health condition studied
The pain induced by cold
ICD-10 code
T33.5
ICD-10 code description
Superficial frostbite of wrist and hand

Primary outcomes

1

Description
Cold pain threshold
Timepoint
Before interventions, First day(After taking pills available in packet No.1), 11th day(after taking pills available in packet No.2), 21th day(After taking pills available in packet No.3), 31th day(After taking pills available in packet No.4), 41th day(After taking pills available in packet No.5).
Method of measurement
The maximum storage time (in minutes) in a mixture of water and ice.

Secondary outcomes

empty

Intervention groups

1

Description
All the participants will take Clonidine and Dextromethorphan and Placebo tablets (Considering a 10 day wash-out period for each dose of medication). Clonidine tablet, 0.2 mg single dose, once during the test, 1.5 hours before test. Dextromethorphan tablet, 0.3 mg/kg single dose, once during the test, 30 minutes before test. Placebo, once during test, 1 hours before test. Clonidine tablet, 0.2 mg single dose with Dextrometorphan tablet, 0.3 mg /kg single dose, once during test, 1 hours before test.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Dr.Amirhossein Orandi
Street address
Imam Khomeini hospital, end of Keshavarz Blvd, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Student's Scientific Research Center of Tehran University of Medical Sciences
Full name of responsible person
Ms.Alizadeh
Street address
Vesal St, Keshavarz Blvd, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Student's Scientific Research Center of Tehran University of Medical Sciences
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Dr.Amirhossein Orandi
Full name of responsible person
Dr.Amirhossein Orandi
Street address
Imam Khomeini hospital, end of Keshavarz Blvd, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dr.Amirhossein Orandi
Proportion provided by this source
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
Porooshat Nazemi
Position
senior student
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, the corner of Qods St, Keshvarz Blvd, Tehran
City
Tehran
Postal code
Phone
+98 910 988 3401
Fax
Email
p-nazemi@student.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Amirhossein Orandi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Imam Khomeini hospital, end of Keshavarz Blvd, Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2828
Fax
Email
horandi@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Porooshat Nazemi
Position
Senior Student
Other areas of specialty/work
Street address
Tehran University of Medical Sciences, the corner of Qods St, Keshvarz Blvd, Tehran
City
Tehran
Postal code
Phone
00
Fax
Email
p-nazemi@student.tums.ac.ir
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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