Effect of oral Tizanidine and Baclofen for the management of postoperative pai

Phase 3

• Conditions: Femur fracture.; Unequal limb length (acquired), femur; M21.75

• Registration Number: IRCT20201014049025N1
• Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Confirmation of femur fracture candidate diagnosis by orthopedic specialist
The patient's desire to participate in the study and gain informed consent
Candidate for non-emergency femur surgery and fracture
Patients aged 25-70 years
No history of allergy to baclofen and tizanidine
Absence of bradycardia (HR <60) in patients
Absence of CNS disease (including epilepsy and seizures)
Absence of kidney disease (Cr>2)

Exclusion Criteria

Using drug 24 hours before the intervention
Occurrence of any unusual complication during surgery and during anesthesia

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain severity. Timepoint: 2, 4, 6, 12, 24, 48 hours after surgery. Method of measurement: Visual Analogue Scale (VAS).

Secondary Outcome Measures

Name	Time	Method
ausea and vomiting. Timepoint: 2, 4, 6, 12, 24, 48 hours after surgery. Method of measurement: Questionnaire.;Itching. Timepoint: 2, 4, 6, 12, 24, 48 hours after surgery. Method of measurement: Questionnaire.;Dry mouth. Timepoint: 2, 4, 6, 12, 24, 48 hours after surgery. Method of measurement: Questionnaire.;Bradycardia. Timepoint: 2, 4, 6, 12, 24, 48 hours after surgery. Method of measurement: Questionnaire.;Headache and dizziness. Timepoint: 2, 4, 6, 12, 24, 48 hours after surgery. Method of measurement: Questionnaire.;Drowsiness. Timepoint: 2, 4, 6, 12, 24, 48 hours after surgery. Method of measurement: Questionnaire.