NCT06638086

Effectiveness Of Intravenous Vs Rectal Acetaminophen For Pain Management In Post Operative Neonates

Effectiveness Of Intravenous Vs Rectal Acetaminophen For Pain Management In Post Operative Neonates; A Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Rawalpindi Medical College · Academic / Other
• Sex: All
• Age: 1 Hour – 28 Days
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial aims to evaluate the effectiveness of intravenous (IV) versus rectal acetaminophen for postoperative pain management in neonates. The study includes postoperative term neonates who require analgesia for at least 12 hours. The main questions the study seeks to answer are: Does IV acetaminophen provide better pain relief compared to rectal administration in neonates? What is the time to rescue analgesia and the efficacy of pain score reduction between these two routes? The study compares 32 neonates receiving IV acetaminophen to 32 neonates administered rectal acetaminophen. Both routes are administered at equivalent bioavailable doses to ensure a fair comparison.

Detailed description

This randomized controlled trial investigates the comparative effectiveness of intravenous (IV) versus rectal administration of acetaminophen for managing postoperative pain in neonates. Neonates, due to their limited physiological reserves and underdeveloped metabolic systems, require precise pain management strategies to prevent potential developmental delays or adverse effects. Acetaminophen, a commonly used analgesic in neonatal care, is metabolized primarily by the liver and excreted via the kidneys. However, its pharmacokinetics vary significantly based on the route of administration, making it important to evaluate which method offers more reliable pain relief. The study includes 64 term neonates who underwent surgery and are expected to require pain relief for at least 12 hours. Preterm and preoperative neonates are excluded. The neonates were randomized into two groups: one receiving acetaminophen intravenously (15 mg/kg) and the other rectally (40 mg/kg), ensuring similar concentrations at the effect site. Key variables include rescue analgesia requirements, time to rescue analgesia, and changes in pain scores. Pain relief efficacy is measured by pain score changes, and any need for additional analgesia is recorded. This study will provide valuable insights into the optimal route for administering acetaminophen in neonates.

Conditions

• Pain Score Reduction
• Effectiveness of Acetaminophen
• Postoperative Pain Management in Neonates
• Rescue Analgesia
• Neonatal Patient

Interventions

Type	Name	Description
DRUG	Acetaminophen Suppositories	Per rectal suppositories
DRUG	Acetaminophen Injection	Intra-venous injection

Timeline

• Start date: 2023-01-10
• Primary completion: 2024-01-10
• Completion: 2024-01-10
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: Pakistan