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Original research
Propofol for endotracheal intubation in neonates: a dose-finding trial
  1. Ellen H.M. de Kort1,2,
  2. Sandra A. Prins3,
  3. Irwin K.M. Reiss2,
  4. Sten P. Willemsen4,
  5. Peter Andriessen1,
  6. Mirjam M. van Weissenbruch3,
  7. Sinno H.P. Simons2
  1. 1 Neonatology, Maxima Medical Center, Veldhoven, The Netherlands
  2. 2 Neonatology, Erasmus MC-Sophia Children's Hospital, Rotterdam, The Netherlands
  3. 3 Neonatology, Amsterdam UMC location VU Medical Center, Amsterdam, The Netherlands
  4. 4 Biostatistics, Erasmus Medical Centre, Rotterdam, The Netherlands
  1. Correspondence to Ellen H.M. de Kort, Neonatal Intensive Care Unit, Maxima Medical Center, 5504 DB Veldhoven, The Netherlands; e.dekort{at}mmc.nl

Abstract

Objective To find propofol doses providing effective sedation without side effects in neonates of different gestational ages (GA) and postnatal ages (PNA).

Design and setting Prospective multicentere dose-finding study in 3 neonatal intensive care units.

Patients Neonates with a PNA <28 days requiring non-emergency endotracheal intubation.

Interventions Neonates were stratified into 8 groups based on GA and PNA. The first 5 neonates in every group received a dose of 1.0 mg/kg propofol. Based on sedative effect and side effects, the dose was increased or decreased in the next 5 patients until the optimal dose was found.

Main outcome measures The primary outcome was the optimal single propofol starting dose that provides effective sedation without side effects in each age group.

Results After inclusion of 91 patients, the study was prematurely terminated because the primary outcome was only reached in 13% of patients. Dose-finding was completed in 2 groups, but no optimal propofol dose was found. Effective sedation without side effects was achieved more often after a starting dose of 2.0 mg/kg (28%) than after 1.0 mg/kg (3%) and 1.5 mg/kg (9%). Propofol-induced hypotension occurred in 59% of patients. Logistic regression analyses showed that GA and PNA did not predict effective sedation or the occurrence of hypotension.

Conclusions Effective sedation without side effects is difficult to achieve with propofol and the optimal dose in different age groups of neonates could not be determined. The sedative effect of propofol and the occurrence of hypotension are unpredictable and show large inter-individual variability in the neonatal population.

  • pharmacology
  • analgesia
  • neonatology
  • pain
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/archdischild-2019-318474

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    Footnotes

    • Contributors EdeK collected data, carried out the initial analysis, drafted the initial manuscript and reviewed and revised the manuscript. SP and PA collected data and reviewed and revised the manuscript. IR coordinated and supervised data collection and reviewed and revised the manuscript. SW carried out the initial statistical analysis and reviewed and revised the manuscript. SS and MvW conceptualised and designed the study, collected data, coordinated and supervised data collection and reviewed and revised the manuscript. All authors approved the final manuscript as submitted and agreed to be accountable for all aspects of the work.

    • Funding This study was financially supported by a grant of Fonds NutsOhra (grant number 1201-020) and a personal grant (SS) of the Netherlands Organization for Health Research and Development (ZonMw 90713494).

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval The local medical ethics committee approved the study (NL47607.078.14, MEC-2014–0.68).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available on reasonable request. Upon personal request, individual participant data that are collected during the trial, can be made available after de-identification.

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