Comparison of continuous infusion of fentanyl to bolus dosing in neonates after surgery

Vaughn, Philip R.; Townsend, Susan F.; Thilo, Elizabeth H.; McKenzie, Shirley; Moreland, Susan G; Kawato, Kerry

doi:10.1016/s0022-3468(96)90033-0

Cited by 33 publications

(8 citation statements)

References 34 publications

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“…Six clinical trials were terminated early because of significant ADRs (15–20). In two trials (15,16), both in neonatology, mortality was found to be higher in the treatment group.…”

Section: Resultsmentioning

confidence: 99%

Safety in paediatric clinical trials – a 7‐year review

et al. 2008

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“…Six clinical trials were terminated early because of significant ADRs (15–20). In two trials (15,16), both in neonatology, mortality was found to be higher in the treatment group.…”

Section: Resultsmentioning

confidence: 99%

Safety in paediatric clinical trials – a 7‐year review

et al. 2008

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“…To our knowledge, this is the first study to compare the serum concentrations and pharmacokinetics of two commonly used regimens of fentanyl for analgesia and sedation in neonates. Previous study comparing CI (1 mcg/kg/hour) and IB (2 mcg/kg once in 2 hours) regimens of fentanyl in postoperative neonates reported comparable efficacy of both the regimens and increased apnoea in the IB regimen 12…”

Section: Discussionmentioning

confidence: 90%

“…The few studies on pharmacokinetics and clinical efficacy of CI regimen of fentanyl were small and were performed in specific population groups 7–11. The only study comparing CI and IB regimen of fentanyl reported only clinical outcomes 12. To our knowledge, there are no data on pharmacokinetics of IB regimen of fentanyl.…”

Section: Introductionmentioning

confidence: 99%

Continuous infusion versus intermittent bolus doses of fentanyl for analgesia and sedation in neonates: an open-label randomised controlled trial

Abiramalatha

Mathew

et al. 2018

Arch Dis Child Fetal Neonatal Ed

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ObjectiveAdequate data on fentanyl pharmacokinetics in neonates are lacking. The study was performed to compare serum concentrations and clinical outcome between continuous infusion (CI) and intermittent bolus (IB) doses of fentanyl for analgesia and sedation in neonates.MethodsIn this open-label randomised controlled trial, neonates requiring 24–48 hours of mechanical ventilation and fentanyl administration were recruited. In CI regimen, 1 mcg/kg loading dose was followed by 1 mcg/kg/hour infusion. In IB regimen, 1mcg/kg/dose was administered every 4 hours.Maximum six blood samples were collected in 48 hours from each baby at prespecified time points for estimating serum fentanyl concentration. Secondary outcomes were pain scores (Neonatal Infant Pain Scale and Neonatal Pain, Agitation and Sedation Scale for acute and ongoing pain, respectively) and incidence of adverse effects of fentanyl.Results100 neonates were recruited, 53 in CI and 47 in IB group. In CI regimen, median (IQR) serum fentanyl concentration was 0.42 (0.35, 0.46) to 0.61 (0.47, 0.89) ng/mL throughout the infusion period. In IB regimen, median (IQR) peak concentration ranged from 2.21 (1.82, 3.55) to 3.61 (2.91, 4.51) ng/mL and trough concentration 0.41 (0.33, 0.48) to 0.97 (0.56, 1.25) ng/mL for various doses.Median (IQR) peak concentration (Cmax, 3.06 (1.09, 4.50) vs 0.78 (0.49, 1.73) ng/mL; p<0.001) was significantly higher and area under concentration-time curve (AUC0–24, 19.6 (10.4, 33.5) vs 13.2 (10.8, 22.6) µg·hour/L; p=0.12) was higher (though not statistically significant) in IB than CI regimen. Pain scores and adverse effects were comparable between the two regimens.ConclusionCI regimen of fentanyl produces steady serum concentrations, whereas IB regimen produces wide fluctuations in serum concentration with high-peak concentrations. A serum fentanyl concentration of 0.4–0.6 ng/mL produces adequate analgesia and sedation in neonates.Trial registration numberCTRI/2014/11/005190.

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“…However, this method, or similar method, using various designs of suction units, has been successful in most studies (Francis et al, 1987;Vaughn et al, 1996;Kiess et al, 1995;Schmidt, 1998;Price et al, 1983;Bettendorf et al, 1998), and is one of the methods recommended by Salimetrics, LLC (PA, USA) the producers of the Salivary Enzyme Immunoassay Kit. This method was also considered by the investigators to be safer and less stressful to the infant than an alternative recommended method of placing a cotton ball swab in the infants' mouth for up to 10 min for collection of saliva.…”

Section: Discussionmentioning

confidence: 99%

“…Results have been variable and have depended on the stimulus, the health of the infants as determined by obstetric history and previous exposure to the stimulus Gunnar et al, 1991). Despite the wide variability in normal salivary cortisol levels and variable responses to both painful and non-painful stimuli, salivary cortisol levels have been used to measure effectiveness of interventions aimed at reducing pain and stress in infants (Kurihara et al, 1996;Felt et al, 2000;Joyce et al, 2001;Vaughn et al, 1996) and for investigating effects of environmental light reduction (Grauer, 1989). The collection of saliva has been reported as being a simple procedure to undertake, resulting in little stress to infants (Chang et al, 1995).…”

mentioning

confidence: 99%