Objective: to determine pain reduction of needle electromyography by taking oral lorazepam and acetaminophen; Study Type: random double-blind, placebo-controlled, single-center; Study population: patients referred to the hospital diagnosis depart of Ali ibn Abi Talib for needle EMG; Inclusion criteria: patients undergoing electromyography, consent to participate in the study; Exclusion criteria: myopathy, neuropathy, mental disorder, use of benzodiazepines in recent days, there is addiction to pain severe underlying neurologist diagnosed; Sample size: 150; Interventions: Administration Lorazepam (2 mg) and acetaminophen with codeine (325mg) and placebo that in this group is folic acid (mg1) . The patients in the waiting room an hour before the procedure by a trained technician who does not know anything about the type of drug being administered medication with a glass of water; The primary outcome: pain reduction; Methods: standard EMG is routinely used for patients. Doctor has no information about the kind of drug, immediately after the EMG, patients will beasked to rate their pain on a visual analogue pain mark.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100324315N1
Registration date:2016-04-06, 1395/01/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-04-06, 1395/01/18
Registrant information
Name
Vajihe Akar
Name of organization / entity
Zahedan Medical University of Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3844 8530
Email address
v.akar@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of acetaminophen-oxicodon and lorazepam for decrease the pain of EMG needeling
Public title
Effect of acetaminophen-oxicodon and lorazepam for decrease the pain of EMG needeling
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing electromyography ;consent to participate in the study;
Exclusion criteria: myopathy; neuropathy; mental disorder; use of benzodiazepines in recent days; there is addiction to pain severe underlying neurologist diagnosed
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
150
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 Zahedan Medical University of Science
Street address
Ethics Committee of Zahedan Medical University of Science, zahedan medical university of science, Dr.Hesabi Square, Daneshgah Avenue, Zahedan
City
Zahedan
Postal code
43181-98167
Approval date
2015-05-24, 1394/03/03
Ethics committee reference number
IR.zaums.res.13934.55
Health conditions studied
1
Description of health condition studied
Evaluation the effect of acetaminophen-oxicodon and lorazepam for decrease the pain of EMG needeling
ICD-10 code
G70, G71,
ICD-10 code description
Diseases of myoneural junction and muscle
Primary outcomes
1
Description
Pain
Timepoint
1 hour after procedure
Method of measurement
VAS Criteria
Secondary outcomes
1
Description
nothing
Timepoint
nothing
Method of measurement
nothing
Intervention groups
1
Description
The second group intervention: administration of 325 mg of acetaminophen codeine orally one hour before performing electromyography
Category
Treatment - Drugs
2
Description
The third group intervention: administration of a milligram of folic acid orally one hour before performing electromyography
Category
Placebo
3
Description
The first group intervention: administration of 2 milligram of diazepam orally one hour before performing electromyography
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebn Abi Taleb Hospital, Zahedan
Full name of responsible person
Vajihe Akar
Street address
Neurology Department, Zahedan Ali ibn Abi Talib Hospital, Salamat Blvd, Dr.Hesabi Sq., Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Hesabi Square, Zahedan
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Zahedan 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
Zahedan Medical University
Full name of responsible person
Vajiheh Akar
Position
Medical Student
Other areas of specialty/work
Street address
Ali-ebn Abi Taleb Hospital,Salamat Blvd, Dr.Hesabi Sq.,Daneshgah Ave., Zahedan zahedan
City
Zahedan
Postal code
98167-43463
Phone
+98 54 3341 1260
Fax
Email
Vajihehakar68@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan Medical University
Full name of responsible person
Dr. Hamed AmiriFard
Position
Neurologist
Other areas of specialty/work
Street address
Ali Ebn Abitaleb Hospital, Salamt Blvd, Dr.Hesabi Sq., Daneshgah Ave.,Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5715
Fax
Email
Dr.amirifard@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Vajiheh Akar
Position
Medical Student
Other areas of specialty/work
Street address
Ali-ebn Abi Taleb Hospital, Khalije Fars Blvd., Zahedan
City
Zahedan
Postal code
Phone
+54 33295580
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)