Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06638086
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Effectiveness Of Intravenous Vs Rectal Acetaminophen For Pain Management In Post Operative Neonates
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness Of Intravenous Vs Rectal Acetaminophen For Pain Management In Post Operative Neonates A Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 mgkg and the other rectally 40 mgkg 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
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 mgkg and the other rectally 40 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None