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

NCT06638086 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-10-15

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

Acetaminophen Suppositories

Per rectal suppositories

DRUG

Acetaminophen Injection

Intra-venous injection

Sponsors & Collaborators

  • Rawalpindi Medical College

    lead OTHER

Principal Investigators

  • Ali Raza Chaudhry, MBBS, MS · Rawalpindi Medical College

  • Mudassar Fiaz Gondal, MBBS, MS · Rawalpindi Medical College

  • Hasnain Aslam, MBBS · Rawalpindi Medical College

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Hour
Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2024-01-10
Completion
2024-01-10

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06638086 on ClinicalTrials.gov