Trial reportArchives of disease in childhood2023
Pharmacokinetics and tolerability of intranasal or intravenous administration of nalbuphine in infants.
Trial report in Archives of disease in childhood, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03059511 (Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants), which is not on this map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants: A Single Center, Open-label, Prospective Study
Who cites it
6 citing papers in PubMed, 8 citations in OpenAlex.
- Determining ED50 of Nalbuphine for Intraoperative Analgesia in Elderly Patients Undergoing Percutaneous Kyphoplasty: A Prospective, Double-Blind, Single-Center, Dose-Finding Study.Journal of pain research · 2026Trial
- Allergic reaction to nalbuphine administration in a pre-adolescent patient: a case report and literature review.BMC anesthesiology · 2026Review
- Primary Mucosal Routes of Opioid Administration for Treating Terminal Cancer Pain: Rectal, Buccal, and Intranasal Delivery.Cancer management and research · 2026Review
- Pharmacokinetic and pharmacodynamic principles: unique considerations for optimal design of neonatal clinical trials.Frontiers in pediatrics · 2023Review
- Pharmacometric Analysis of Intranasal and Intravenous Nalbuphine to Optimize Pain Management in Infants.Frontiers in pediatrics · 2022Article
- Nasal nalbuphine analgesia in prehospital trauma managed by first-responder personnel on ski slopes in Switzerland: an observational cohort study.Scandinavian journal of trauma, resuscitation and emergency medicine · 2021Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesIntranasal nalbuphine could be a safe, efficacious and non-invasive alternative to parenteral pain medication in infants. We aimed to assess pharmacokinetics (PK) and tolerability of intranasal and intravenous nalbuphine administration in infants.
methodsProspective open-label study including infants 1-3 months of age admitted to the emergency department, receiving nalbuphine for procedural pain management. Patients were alternately allocated to a single nalbuphine dose of 0.05 mg/kg intravenously or 0.1 mg/kg intranasally. Nalbuphine PK samples were collected 15, 30 and 120-180 min after dosing. Area under the concentration time curve (AUC
resultsOut of 52 study subjects receiving nalbuphine, 31 were eligible for NCA (11 intravenous, 20 intranasal). Median AUC
conclusionThis is the first study investigating intranasal administration of nalbuphine in infants suggesting an intranasal bioavailability close to 50%. Non-invasive intranasal application was well tolerated. Additional studies are warranted to optimise dosing and timing of interventions as C TRIAL REGISTRATION NUMBER: NCT03059511.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.