Clinical trial NCT06638086: Effectiveness Of Intravenous Vs Rectal Acetaminophen For Pain Management In Post Operative Neonates
Official title: Effectiveness Of Intravenous Vs Rectal Acetaminophen For Pain Management In Post Operative Neonates; A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain Score Reduction
Effectiveness of Acetaminophen
Postoperative Pain Management in Neonates
Rescue Analgesia
Neonatal Patient
Keywords: Neonatal analgesia protocols
Neonatal care
Pain score reduction
Neonatal pain management
Acetaminophen in neonates
Pediatric surgery pain relief
Lead sponsor: Rawalpindi Medical College
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 64
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The interventional study model for this article is a Parallel Assignment model.

In this study, neonates are randomly assigned to one of two groups: one group receives intravenous (IV) acetaminophen, and the other group receives rectal acetaminophen. The outcomes, such as the need for rescue analgesia, time to rescue analgesia, and reduction in pain scores, are then compared between these two parallel groups to assess the effectiveness of the different administration routes for managing postoperative pain in neonates.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in pain score
timeFrame: 0 to 6 hours
measure: Time for rescue analgesia
timeFrame: 0 to 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Department of Pediatric Surgery,Holy Family Hospital
state: Punjab
Study officials:
affiliation: Rawalpindi Medical College
name: Ali Raza Chaudhry, MBBS, MS
role: STUDY_DIRECTOR
affiliation: Rawalpindi Medical College
name: Mudassar Fiaz Gondal, MBBS, MS
role: STUDY_CHAIR
affiliation: Rawalpindi Medical College
name: Hasnain Aslam, MBBS
role: PRINCIPAL_INVESTIGATOR
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