CompletedNot Applicable

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

Pakistan64 participantsStarted 2023-01-10

Plain-language 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.

Who can participate

Age range

1 Hour – 28 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

change in pain score

Timeframe: 0 to 6 hours

Time for rescue analgesia

Timeframe: 0 to 6 hours

Trial details

NCT IDNCT06638086

SponsorRawalpindi Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-01-10

View on ClinicalTrials.gov More Pain Score Reduction trials