Effectiveness of Acetaminophen, Neonatal Patient, Pain Score Reduction, Postoperative Pain Management in Neonates, Rescue Analgesia
Conditions
Keywords
Neonatal analgesia protocols, Neonatal care, Pain score reduction, Neonatal pain management, Acetaminophen in neonates, Pediatric surgery pain relief
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.
Interventions
DRUGAcetaminophen Suppositories
Per rectal suppositories
Intra-venous injection
Sponsors
Rawalpindi Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
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.
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.
Eligibility
Sex/Gender
ALL
Age
1 Hours to 28 Days
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time for rescue analgesia | 0 to 6 hours | time will be measured and compared |
| change in pain score | 0 to 6 hours | Bernese Pain Scale for Neonates will be used consisting of total score of 27 |
Countries
Pakistan
Outcome results
None listed