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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Per-rectal group | Experimental | These neonates received Acetaminophen per rectally at dose of 40 mg/kg. |
|
| Intra-vanous group | Active Comparator | These neonates received intravenous Acetaminophen at dose of 15 mg/kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen Suppositories | Drug | Per rectal suppositories |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatric Surgery,Holy Family Hospital | Rawalpindi | Punjab Province | 46000 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19307058 | Result | 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. | |
| 22935063 |
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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.
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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.
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| Acetaminophen Injection | Drug | Intra-venous injection |
|
|
| Cuzzolin L, Antonucci R, Fanos V. Paracetamol (acetaminophen) efficacy and safety in the newborn. Curr Drug Metab. 2013 Feb;14(2):178-85. |
| 19192939 | Result | Duggan ST, Scott LJ. Intravenous paracetamol (acetaminophen). Drugs. 2009;69(1):101-13. doi: 10.2165/00003495-200969010-00007. |
| 17262050 | 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. |
| 10492416 | 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. |
| 12170045 | 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. |
| 18211998 | 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. |
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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