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

Comparison the effect of oral Tizanidine and Baclofen for the management of postoperative pain after femur fracture surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20201014049025N1
Enrollment
50
Registered
2020-11-20
Start date
2020-12-04
Completion date
Unknown
Last updated
2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femur fracture. Unequal limb length (acquired), femur

Interventions

Intervention 1: Intervention group: One 4 mg tizanidine tablet orally (made by Galenus) (3 hours prior to single dose anesthesia). Intervention 2: Intervention group: One 25 mg Baclofen tablet orally

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 70 Years

Inclusion criteria

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 2)

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
Nausea 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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Ali Safarpour

Mazandaran University of Medical Sciences

ali_safarpour707@yahoo.com+98 11 3304 4000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026