Comparing intravenous paracetamol and ibuprofen in pediatric cleft palate surgeries for post operative analgesia

Comparing pain management outcomes: Pre-emptive intravenous Paracetamol versus Ibuprofen in pediatric cleft palate surgeries under General Anaesthesia - a single blinded randomised controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/097713

Enrollment

108

Registered

2025-11-19

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-08

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

Conditions

Health Condition 1: Q359- Cleft palate, unspecified Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: Ibuprofen: Intravenous Ibuprofen is given pre-emptively as a single dose of 10mg/kg body weight in cleft palate surgeries to reduce post operative pain. Control Intervention1: Paracetam

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 1-5yrs, ASA grade I and II, undergoing cleft palate surgeries under general anaesthesia

Exclusion criteria

Exclusion criteria: patients of ASA grades III or IV, hypersensitive to NSAIDs or those with existing cardiac or respiratory disorders.

Design outcomes

Primary

Measure	Time frame
effectiveness of paracetamol and ibuprofen for postoperative pain for cleft palate surgeriesTimepoint: Pain score immediately assessed after completion of surgery when patient is shifted to the recovery	—

Secondary

Measure	Time frame
efficacy of ibuprofen & paracetamol in reducing post operative opioid consumption in cleft palate surgeriesTimepoint: 24 hours after surgery;stable post operative hemodynamics for cleft palate surgeriesTimepoint: 24 hours after surgery	—

Countries

India

Contacts

Public ContactTanushree Potluri

Jawaharlal Nehru Medical College, KLE University

purvashreedeshmukh@gmail.com7026083555

Outcome results

None listed

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