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Comparing the effect of intravenous analgesia and thoracic epidural analgesia on the duration of mechanical ventilation in pediatric patients undergoing heart surgery

A comparative study on efficacy of thoracic epidural versus intravenous analgesia on duration of ventilation in pediatric cardiac surgery- a prospective randomized control study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/05/086143
Enrollment
68
Registered
2025-05-02
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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: Administration of bupivacaine with morphine through thoracic epidural in pediatric cardiac surgery: In epidural group we administrer bupivacaine along with morphine through thoracic epi

Sponsors

Pooja Chandran
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Paediatric patients one month to 12 years 2. Stat 1, 2, 3, and 4 category surgeries 3. ASA status I, II, and III with sinus rhythm 4. Elective cardiac surgery 5. Surgery with midline sternotomy /thoracotomy

Exclusion criteria

Exclusion criteria: 1. Deranged coagulation profile 2. refusal to participate in study 3. Local anaesthetic allergy 4.Low cardiac output syndrome 5. STAT Cat 5

Design outcomes

Primary

MeasureTime frame
Comparison of epidural analgesia (bupivacaine + morphine) added to general anaesthesia vs general anaesthesia plus systemic analgesia (fentanyl) on duration of mechanical ventilation in paediatric cardiac surgery.Timepoint: At the time of extubation

Secondary

MeasureTime frame
Comparison of epidural analgesia (bupivacaine +morphine) added to general anaesthesia vs general anaesthesia plus systemic analgesia (fentanyl) on postoperative pain score using FLACC scale at 6 hours, 12 hours, & 24 hours in paediatric cardiac surgery.Timepoint: At 12 hours , 24 hours & 48 hours after surgery.;Comparison of epidural analgesia (bupivacaine + morphine) added to general anaesthesia vs general anaesthesia plus systemic analgesia (fentanyl) on length of ICU stay in paediatric cardiac surgeryTimepoint: from the time of admission in the ICU to shifting to ward;Comparison of epidural analgesia (bupivacaine + morphine) added to general anaesthesia vs general anaesthesia plus systemic analgesia (fentanyl) on postoperative length of stay (PLOS) in paediatric cardiac surgeryTimepoint: from the time of admission in the ICU postoperatively to discharge from hospital, which is calculated in days;Comparison of epidural analgesia (bupivacaine + morphine) added to general anaesthesia vs general anaesthesia plus systemic analgesia (fentanyl) on vasoactive inotrope score (VIS) in paediatric cardiac surgeryTimepoint: Checked at 12 hours, 24 hours & 48 hours postoperatively;Comparison of epidural analgesia (bupivacaine + morphine) added to general anaesthesia vs general anaesthesia plus systemic analgesia (fentanyl) on re-operation, cumulative postoperative morbidity, in paediatric cardiac surgeryTimepoint: morbidity checked at 12 hours, 24 hours & 48 hours postoperatively;Comparison of epidural analgesia (bupivacaine + morphine) added to general anaesthesia vs general anaesthesia plus systemic analgesia (fentanyl) on the difference in duration of resumption of enteral feed in paediatric cardiac surgeryTimepoint: postoperatively the time at which semi solid feed starts

Countries

India

Contacts

Public ContactDr Ajay Kumar

All India Institute of Medical Sciences, Rishikesh

ajaymishra0701@gmail.com9340482058

Outcome results

None listed

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