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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2024-01-10

Brief Summary

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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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Detailed Description

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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

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

The primary investigator collects and analyzes the data using self-designed questionnaires. Typically, in such studies, the intervention (route of acetaminophen) would be known to the healthcare providers administering. Therefore, masking of the participants and providers might not be feasible.

Study Groups

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Per-rectal group

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

Group Type EXPERIMENTAL

Acetaminophen Suppositories

Intervention Type DRUG

Per rectal suppositories

Intra-vanous group

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

Group Type ACTIVE_COMPARATOR

Acetaminophen Injection

Intervention Type DRUG

Intra-venous injection

Interventions

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Acetaminophen Suppositories

Per rectal suppositories

Intervention Type DRUG

Acetaminophen Injection

Intra-venous injection

Intervention Type DRUG

Other Intervention Names

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Napa Suppositories Provase

Eligibility Criteria

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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

Minimum Eligible Age

1 Hour

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No