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Completed

NCT Number: NCT06638086

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

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.

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Key information

Age range

1 hour–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric Surgery,Holy Family Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acetaminophen Suppositories

Drug

Per rectal suppositories

Other names: Napa Suppositories

Acetaminophen Injection

Drug

Intra-venous injection

Other names: Provase

Primary outcomes

  1. change in pain score

    Time frame: 0 to 6 hours

    "Bernese Pain Scale for Neonates" will be used consisting of total score of 27

  2. Time for rescue analgesia

    Time frame: 0 to 6 hours

    time will be measured and compared

Sponsors and collaborators

Lead sponsor

Rawalpindi Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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