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

Not Applicable

Completed

• Conditions: Pain Score Reduction; Effectiveness of Acetaminophen; Postoperative Pain Management in Neonates; Rescue Analgesia; Neonatal Patient
• Interventions: Drug: Acetaminophen Suppositories; Drug: Acetaminophen Injection

• Registration Number: NCT06638086
• Lead Sponsor: Rawalpindi Medical College

Brief 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.

Study Timeline

• Study Start: 2023-01-10
• Primary Completion: 2024-01-10
• Study Completion: 2024-01-10
• Status Verified: 2024-10
• Study First Submitted: 2024-10-08
• Study First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-09
• Study First Posted: 2024-10-11
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• All post-operative neonates requiring acetaminiphen as analgesia.

Exclusion Criteria

• All neonates requiring any other kind of Pain relief medication (Nerve block or local analgesia)
• All neonates in neonatal ICU
• All neonates with central venous line in place
• All neonates that are on ventilatory support

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Per-rectal group	Acetaminophen Suppositories	These neonates received Acetaminophen per rectally at dose of 40 mg/kg.
Intra-vanous group	Acetaminophen Injection	These neonates received intravenous Acetaminophen at dose of 15 mg/kg.

Primary Outcome Measures

Name	Time	Method
change in pain score	0 to 6 hours	"Bernese Pain Scale for Neonates" will be used consisting of total score of 27
Time for rescue analgesia	0 to 6 hours	time will be measured and compared

Trial Locations

Locations (1)

Department of Pediatric Surgery,Holy Family Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan