Pharmacokinetic Alteration of Pethidine in Patients Following Lower-Limb Orthopedic Surgery.
Phase 3
- Conditions
- Fracture of Lower Limb.Fracture of lower limb, level unspecified
- Registration Number
- IRCT201508093106N28
- Lead Sponsor
- Vice Chancellor for Research Affairs, Islamic Azad University, Pharmaceutical Sciences Branch
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 12
Inclusion 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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of pain intensity. Timepoint: 5, 30, 60 and 180 minutes after drug injection. Method of measurement: Based on Visual Analogue Scale (VAS).;Measuring blood levels of pethidine. Timepoint: 5, 30, 60 and 180 minutes after injection. Method of measurement: with HPLC Method.
- Secondary Outcome Measures
Name Time Method Adverse drug reactions. Timepoint: 5, 30, 60 and 180 minutes after injection of the drug. Method of measurement: Observation and clinical studies.