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A clinical trial is being conducted to investigate the impact of preoperative oral dose of tizanidine on pain after the operation in maxillofacial trauma cases.

Effect of pre-emptive oral tizanidine on post-operative pain after open reduction and internal fixation in maxillofacial trauma: a double blind randomized controlled trial - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/059108
Enrollment
32
Registered
2023-10-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Group A: Patients will be kept on NPO for 6 hours pre-operatively. One hour prior to being transferred to the operating rooms, intervention patients will be given oral tizanidine 4mg wi

Sponsors

All India Institute of Medical Sciences Patna
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients planned for ORIF under general anesthesia for maxillofacial trauma will be included in the study. 1. Age between 18 and 65 years 2. ASA-PS Grade 1 & 2 3. BMI

Exclusion criteria

Exclusion criteria: 1. Patient refusal to participate in the study 2. Patients with known hypersensitivity to study medications. 3. Patients with renal or hepatic insufficiency 4. Patients on anti-hypertensive drugs, sedatives or alpha-2 agonists

Design outcomes

Primary

MeasureTime frame
To assess the effect of tizanidine as a premedication on post-operative pain relief, as measured by the visual analog scale (VAS), in patients undergoing open reduction and internal fixation (ORIF) for maxillofacial trauma under general anesthesia.Timepoint: Postoperative period at 24 hours

Secondary

MeasureTime frame
- To evaluate the requirement of rescue analgesic - To evaluate post-operative sedation - To monitor and evaluate haemodynamic parameters-heart rate (HR) and mean arterial pressure (MAP) - To assess incidence of PONVTimepoint: post-operative period at the intervals of 2, 6, 12 and 24 hours

Countries

India

Contacts

Public ContactDr Kunal Singh

All India Institute of Medical Sciences Patna

drsinghkunal@gmail.com9411514945

Outcome results

None listed

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