Pharmacokinetic Alteration of Pethidine in Patients Following Lower-Limb Orthopedic Surgery and its Relationship with the Intensity of Pain in these Patients.
The aim of the present study was to investigate possible relationship between blood levels of pethidine and intensity of pain in patients following orthopedic surgery in inferior limb. Twelve patients who underwent orthopedic surgery of the lower limbs and were classified as class I patients (according to the American society of anesthesiologists physical status classification) were included in the present single arm study. They were all between the age range of 18 and 35 years, having full consciousness and experiencing post-operative pain. Those undergoing emergency surgical operations and having abnormal paraclinical tests were excluded from the study. The study was conducted at Sina hospital. After the surgery, following the transference of the patient to the recovery section, 25 mg pethidine was injected intravenously using standard method for local (spinal) anesthesia for pain control. Then, 5, 30, 60 and 180 minutes after injection, blood samples were taken and concentration of pethidine in blood samples were measured by HPLC method. Moreover, patients’ pain intensity was assessed on visual analogue scales. As secondary outcome measures, any possible adverse drug reactions were monitored. Finally, the possible relationship between pharmacokinetic alteration of pethidine and pain intensity of the patients undergoing lower-limb surgery was calculated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508093106N28
Registration date:2015-12-24, 1394/10/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-12-24, 1394/10/03
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research Affairs, Islamic Azad University, Pharmaceutical Sciences Branch.
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pharmacokinetic Alteration of Pethidine in Patients Following Lower-Limb Orthopedic Surgery and its Relationship with the Intensity of Pain in these Patients.
Public title
Pharmacokinetic Alteration of Pethidine in Patients Following Lower-Limb Orthopedic Surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria include:
Age between 18 and 35 years; Not having substance abuse; Having physical and mental health; Having post-operative pain; Having full consciousness; Being classified as class I patients (according to the American society of anesthesiologists physical status classification).
Exclusion Criteria include:
Pregnancy; Lactation; Having seizures; Having psychiatric disorders; Undergoing emergency surgical operations; Having abnormal paraclinical tests.
Age
From 18 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Pharmaceutical Sciences Branch (IAUPS).
Street address
No.99 Yakhchal Street, Shariati Avenue.
City
Tehran
Postal code
1941933111
Approval date
2015-06-13, 1394/03/23
Ethics committee reference number
IR.IAU.PS.REC.1394.5
Health conditions studied
1
Description of health condition studied
Fracture of Lower Limb
ICD-10 code
T12
ICD-10 code description
Fracture of lower limb, level unspecified
Primary outcomes
1
Description
Assessment of pain intensity.
Timepoint
5, 30, 60 and 180 minutes after drug injection
Method of measurement
Based on Visual Analogue Scale (VAS)
2
Description
Measuring blood levels of pethidine
Timepoint
5, 30, 60 and 180 minutes after injection
Method of measurement
with HPLC Method
Secondary outcomes
1
Description
Adverse drug reactions.
Timepoint
5, 30, 60 and 180 minutes after injection of the drug.
Method of measurement
Observation and clinical studies.
Intervention groups
1
Description
After the surgery and following transference of the patients to the recovery section, 25 mg pethidine was injected intravenously.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr. Farshad Hashemian
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research Affairs, Islamic Azad University, Pharmaceutical Sciences Branch
Full name of responsible person
Dr. Sepideh Arbabi
Street address
No.99, Yakhchal St., Dr. Shariati Ave.
City
Tehran
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 Affairs, Islamic Azad University, Pharmaceutical Sciences Branch
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
Islamic Azad University, Pharmaceutical Sciences Branch, Faculty of Pharmacy
Full name of responsible person
Dr. Farshad Hashemian
Position
Dean of School of Pharmacy, Associate Professor/ Pharm.D., Pharmacotherapy Specialist
Other areas of specialty/work
Street address
No.99, Yakhchal St., Dr. Shariati Ave.
City
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Fax
Email
hashemian.f@iaups.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Pharmaceutical Sciences Branch, Faculty of Pharmacy.
Full name of responsible person
Dr. Farshad Hashemian
Position
Dean of School of Pharmacy, Associate Professor/ Pharm.D., Pharmacotherapy Specialist
Other areas of specialty/work
Street address
No.99, Yakhchal St., Dr. Shariati Ave.
City
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Fax
Email
hashemian.f@iaups.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University, Pharmaceutical Sciences Branch (IAUPS)
Full name of responsible person
Shima Afshar
Position
Pharm.D.
Other areas of specialty/work
Street address
No.99 , Yakhchal St. Shariati Ave.
City
Tehran
Postal code
Phone
+98 21 2264 0056
Fax
Email
afshar.shiima@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)