Objectives and Design:
This study is a cross over double blind placebo controlled trial to evaluate the analgesic effects of Tramadol/Paracetamol in healthy volunteers undergoing electromyography procedure.
Setting and conduct:
Prior to EMG study 2 tramadol/paracetamol or placebo tablets are given to each subject and then the EMG study will be done in 4 muscle areas (first dosal interoseous, Biceps, Vastus lateralis and Tibialis Anterior) of each subject (half side in each session) and pain scale is evaluated immediately after the procedure and over the next 2 hours using VAS (visual analogue scale) pain scale scoring system.
Next session is arranged 2 weeks later which VAS pain scoring is done with the mentioned fashion above on the opposite body side of participants. In this session Tramadol/Paracetamol group receives placebo and vice-versa.
Participants:
Ninety subjects aged between 18-50 years will be recruited. Exclusion criteria includes: Epilepsy; Opioid hypersensitivity; Diabetes; Liver or Kidney dysfunction; Severe respiratory disease(asthma or Chronic Obstructive Pulmonary Disease); Opioid use or abuse; Selective Serotonin Reuptake Inhibitors or MAO inhibitor or analgesic use; Tricyclic Antidepressants or Neuroleptic use.
Intervention:
Electromyography and Tramadol/paracetamol tablet.
Main outcome measures:
Main outcome measures includes Visual Analogue Scale for pain scoring.
data will be analyzed using SPSS program.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012111011424N1
Registration date:2013-04-24, 1392/02/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-24, 1392/02/04
Registrant information
Name
Abbas Tafakhori
Name of organization / entity
Iranian Center of Neurological Research
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 0491
Email address
a_tafakhori@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, ،Tehran University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-08-23, 1392/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Tramadol/paracetamol versus placebo as an analgesic in patients undergoing Electromyography study
Public title
Evaluation of Tramadol/Paracetamol versus placebo in reducing pain of Electromyography study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria includes: normal subject aged between 18-50 years.
Exclusion criteria includes: Epilepsy; Opioid hypersensitivity; Diabetes; Liver or Kidney dysfunction; Severe respiratory disease(asthma or Chronic Obstructive Pulmonary Disease); Opioid use or abuse; Selective Serotonin Reuptake Inhibitors or MAO inhibitor or analgesic use; Tricyclic Antidepressants or Neuroleptic use.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
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 Ethics Comittee
Street address
Qods Avenue, Tehran
City
Tehran
Postal code
1419733141
Approval date
2012-09-01, 1391/06/11
Ethics committee reference number
130/1176/د/91
Health conditions studied
1
Description of health condition studied
pain
ICD-10 code
M79.6
ICD-10 code description
pain in limb
Primary outcomes
1
Description
Visual Analog Scale (VAS) score
Timepoint
after and 2 hours after EMG
Method of measurement
estimation of pain severity on 100 scale
Secondary outcomes
1
Description
side effects
Timepoint
after and 2 hours after drug consumption
Method of measurement
asking patient
Intervention groups
1
Description
two Tramadol/paracetamol(37.5/325 mg) tablets 2 hours before EMG study is done in every session.
Category
Treatment - Drugs
2
Description
two placebo tablets 2 hours before EMG study is done in every session.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Center of Neurological research, Imam Khomeini Hospital Complex