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COMPARISON OF ORAL TAPENTADOL AND ORAL PREGABALIN- TWO ANALGESIC DRUGS FOR PAIN RELIEF IN HEART SURGERIES

EFFICACY AND SAFETY OF PRE-EMPTIVE USE OF ORAL TAPENTADOL VERSUS ORAL PREGABALIN FOR POST OPERATIVE ANALGESIA FOLLOWING CARDIAC SURGERY: A COMPARATIVE STUDY

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/037858
Enrollment
66
Registered
2021-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2022-02-21

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

Conditions

Health Condition 1: I251- Atherosclerotic heart disease of native coronary artery

Interventions

Control Intervention1: Capsule pregabalin: To check the effect of he drug for post operative analgesia when given preoperatively Dose- 150 mg Frequency- just once preoperatively Route of administrati

Sponsors

Dr RIYA SHAH
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients posted for elective cardiac surgery using midline sternotomy incision under general anaesthesia 2. Both males and females 3. Age group between 18-65 years, 4. Patients weighing between 40 kg â?? 85 kg

Exclusion criteria

Exclusion criteria: 1. Patients with persistent nausea or vomiting at the time of randomization 2. Patients on mono amino oxidase inhibitors, tricyclic antidepressants, serotonin norepinephrine reuptake inhibitors 3. Patients with Epilepsy, traumatic brain injury, stroke, transient ischemic attack, or brain tumor 4. Patients with opioid tolerance or opioid dependence 5. Patients having renal disease (creatinine >1.4 mg/dL) 6. Patients having liver disease (total bilirubin >1.5 mg/dL) 7. Patients having known allergies to any of the study drug 8. Patients having major psychiatric disorder 9. Pregnancy 10. Patients with left ventricular dysfunction (ejection fraction

Design outcomes

Primary

MeasureTime frame
To compare following parameters in both the groups 1) Duration of analgesia 2) Haemodynamic parameters (heart rate & mean arterial pressure) 3) Adverse effect such as headache and nausea, vomiting 4) Sedation score. Timepoint: Post operatively 0,3,6,12,24 hourly

Secondary

MeasureTime frame
To compare following parameters in both the groups 1) Total consumption of analgesic agents in the post operative period 2) Intra operative analgesic (Fentanyl) requirement Timepoint: 1 year

Countries

India

Contacts

Public ContactRIYA JAYANT SHAH

MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD

vasantikelkar70@gmail.com9370668196

Outcome results

None listed

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