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

Rawalpindi Medical University

Status: Completed

Conditions: Pain Score Reduction; Rescue Analgesia; Postoperative Pain Management in Neonates; Effectiveness of Acetaminophen; Neonatal Patient

Treatments: Drug: Acetaminophen Injection; Drug: Acetaminophen Suppositories

Study type: Interventional

Funder types: Other

Identifiers

NCT06638086

RMU-RRF-SUR-008-23

Details and patient eligibility

About

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.

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 1 hour to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Per-rectal group

Experimental group

Description:

These neonates received Acetaminophen per rectally at dose of 40 mg/kg.

Treatment:

Drug: Acetaminophen Suppositories

Intra-vanous group

Active Comparator group

Description:

These neonates received intravenous Acetaminophen at dose of 15 mg/kg.

Treatment:

Drug: Acetaminophen Injection