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

NCT06638086 | Completed

• 1 other identifier: RMU-RRF-SUR-008-23
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Neonatal analgesia protocols; Neonatal care; Pain score reduction; Neonatal pain management; Acetaminophen in neonates; Pediatric surgery pain relief

Outcome Measures

Primary Outcomes (2)

• change in pain score

  "Bernese Pain Scale for Neonates" will be used consisting of total score of 27

  0 to 6 hours

• Time for rescue analgesia

  time will be measured and compared

  0 to 6 hours

Study Arms (2)

Per-rectal group

EXPERIMENTAL

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

Drug: Acetaminophen Suppositories

Intra-vanous group

ACTIVE COMPARATOR

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

Drug: Acetaminophen Injection

Interventions

Acetaminophen Suppositories DRUG

Per rectal suppositories

Also known as: Napa Suppositories

Per-rectal group

Acetaminophen Injection DRUG

Intra-venous injection

Also known as: Provase

Intra-vanous group

Eligibility Criteria

• Age: 1 Hour - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All post-operative neonates requiring acetaminiphen as analgesia.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rawalpindi Medical College: lead

Study Sites (1)

Department of Pediatric Surgery,Holy Family Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (7)

• Grunau RE, Whitfield MF, Petrie-Thomas J, Synnes AR, Cepeda IL, Keidar A, Rogers M, Mackay M, Hubber-Richard P, Johannesen D. Neonatal pain, parenting stress and interaction, in relation to cognitive and motor development at 8 and 18 months in preterm infants. Pain. 2009 May;143(1-2):138-46. doi: 10.1016/j.pain.2009.02.014.

  PMID: 19307058 RESULT

• Cuzzolin L, Antonucci R, Fanos V. Paracetamol (acetaminophen) efficacy and safety in the newborn. Curr Drug Metab. 2013 Feb;14(2):178-85.

  PMID: 22935063 RESULT

• Duggan ST, Scott LJ. Intravenous paracetamol (acetaminophen). Drugs. 2009;69(1):101-13. doi: 10.2165/00003495-200969010-00007.

  PMID: 19192939 RESULT

• Walls L, Baker CF, Sarkar S. Acetaminophen-induced hepatic failure with encephalopathy in a newborn. J Perinatol. 2007 Feb;27(2):133-5. doi: 10.1038/sj.jp.7211641.

  PMID: 17262050 RESULT

• Hansen TG, O'Brien K, Morton NS, Rasmussen SN. Plasma paracetamol concentrations and pharmacokinetics following rectal administration in neonates and young infants. Acta Anaesthesiol Scand. 1999 Sep;43(8):855-9. doi: 10.1034/j.1399-6576.1999.430813.x.

  PMID: 10492416 RESULT

• Anderson BJ, van Lingen RA, Hansen TG, Lin YC, Holford NH. Acetaminophen developmental pharmacokinetics in premature neonates and infants: a pooled population analysis. Anesthesiology. 2002 Jun;96(6):1336-45. doi: 10.1097/00000542-200206000-00012.

  PMID: 12170045 RESULT

• Capici F, Ingelmo PM, Davidson A, Sacchi CA, Milan B, Sperti LR, Lorini L, Fumagalli R. Randomized controlled trial of duration of analgesia following intravenous or rectal acetaminophen after adenotonsillectomy in children. Br J Anaesth. 2008 Feb;100(2):251-5. doi: 10.1093/bja/aem377.

  PMID: 18211998 RESULT

MeSH Terms

Interventions

Acetaminophen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ali Raza Chaudhry, MBBS, MS

  Rawalpindi Medical College

  STUDY DIRECTOR

• Mudassar Fiaz Gondal, MBBS, MS

  Rawalpindi Medical College

  STUDY CHAIR

• Hasnain Aslam, MBBS

  Rawalpindi Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 15, 2024
• Study Start: January 10, 2023
• Primary Completion: January 10, 2024
• Study Completion: January 10, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)