Pharmacological interventions for pain and sedation management in newborn infants undergoing therapeutic hypothermia

Bäcke, Pyrola; Bruschettini, Matteo; Sibrecht, Greta; Blomqvist, Ylva Thernström; Olsson, Eva‐Karin

doi:10.1002/14651858.cd015023

Cited by 8 publications

(7 citation statements)

References 64 publications

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“…Limited dosing information is currently available on drugs that are commonly administered to HIE neonates receiving TH [37][38][39][40]. Because of alterations in drug PKs, this vulnerable population requires unique clinical pharmacologic considerations [15][16][17][18][19].…”

Section: Discussionmentioning

confidence: 99%

Continuous Fentanyl Infusion in Newborns with Hypoxic–Ischemic Encephalopathy Treated with Therapeutic Hypothermia: Background, Aims, and Study Protocol for Time-Concentration Profiles

Lugli,

Garetti,

Goffredo

et al. 2023

Biomedicines

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Therapeutic hypothermia (TH) is the standard of care for newborns with moderate to severe hypoxic–ischemic encephalopathy (HIE). Discomfort and pain during treatment are common and may affect the therapeutic efficacy of TH. Opioid sedation and analgesia (SA) are generally used in clinical practice, and fentanyl is one of the most frequently administered drugs. However, although fentanyl’s pharmacokinetics (PKs) may be altered by hypothermic treatment, the PK behavior of this opioid drug in cooled newborns with HIE has been poorly investigated. The aim of this phase 1 study protocol (Trial ID: FentanylTH; EUDRACT number: 2020-000836-23) is to evaluate the fentanyl time-concentration profiles of full-term newborns with HIE who have been treated with TH. Newborns undergoing TH receive a standard fentanyl regimen (2 mcg/Kg of fentanyl as a loading dose, followed by a continuous infusion—1 mcg/kg/h—during the 72 h of TH and subsequent rewarming). Fentanyl plasma concentrations before bolus administration, at the end of the loading dose, and 24-48-72-96 h after infusion are measured. The median, maximum, and minimum plasma concentrations, together with drug clearance, are determined. This study will explore the fentanyl time-concentration profiles of cooled, full-term newborns with HIE, thereby helping to optimize the fentanyl SA dosing regimen during TH.

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Section: Discussionmentioning

confidence: 99%

Continuous Fentanyl Infusion in Newborns with Hypoxic–Ischemic Encephalopathy Treated with Therapeutic Hypothermia: Background, Aims, and Study Protocol for Time-Concentration Profiles

Lugli,

Garetti,

Goffredo

et al. 2023

Biomedicines

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“…We could not find other systematic reviews addressing the topic of our study. The protocol of a Cochrane review has been published, however it will include only randomized trials and a narrower list of drugs [ 35 ].…”

Section: Discussionmentioning

confidence: 99%

Interventions for the Management of Pain and Sedation in Newborns Undergoing Therapeutic Hypothermia for Hypoxic-Ischemic Encephalopathy: A Systematic Review

et al. 2022

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Background Newborn infants undergoing therapeutic hypothermia (TH) are exposed to multiple painful and stressful procedures. The aim of this systematic review was to assess benefits and harms of pharmacological and non-pharmacological interventions for the management of pain and sedation in newborn infants undergoing TH for hypoxic-ischemic encephalopathy. Methods We included randomized and observational studies reporting any intervention (either drugs or non-pharmacological interventions) to manage pain and sedation in newborn infants (> 33 weeks' gestational age) undergoing TH. We included any dose, duration and route of administration. We also included any type and duration of non-pharmacological interventions. Our prespecified primary outcomes were analgesia and sedation assessed using validated pain scales in the neonatal population; circulatory instability; mortality to discharge; and neurodevelopmental disability. A systematic literature search was conducted in the PubMed, Embase, CINAHL, Cochrane CENTRAL, Scopus, and Web of Science databases, with no language restrictions. Included studies underwent risk-of-bias assessment (Cochrane risk-of-bias tool and ROBINS-I) and data extraction performed by two authors independently. The plan had been to use effect measures such as mean difference for continuous outcomes and risk ratio for dichotomous outcomes, however the included studies are presented in a narrative synthesis due to their paucity and heterogeneity. Results Ten studies involving 3551 infants were included-one trial and nine observational studies. Most studies examined the use of phenobarbital or other antiepileptic drugs with primary outcomes related to seizure activity. The single trial that was included compared pentoxifylline with placebo. Among the primary outcomes, six studies reported circulatory instability and five reported mortality to discharge without relevant differences; two studies reported on neurodevelopmental disability and one study reported on pain scale. Three studies were ongoing. Conclusions We found limited evidence to establish the benefits and harms of the interventions for the management of pain and sedation in newborn infants undergoing TH. Long-term outcomes were not reported. Given the very low certainty of evidence-due to imprecision of the estimates, inconsistency and limitations in study design (all nine observational studies with overall serious risk of bias)-for all outcomes, clinical trials are required to determine the most effective interventions in this population. Systematic Review Registration PROSPERO registration number: CRD42020205755.

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“…Cochrane Reviews on opioid administration in newborn infants for postoperative pain (Kinoshita 2021a;Kinoshita 2021b), sedation during mechanical ventilation (Bellù 2021), pain or sedation management during therapeutic hypothermia (Bäcke 2021), elective endotracheal intubation (Ayed 2017), and the prevention of pain during endotracheal suctioning (Pirlotte 2019), are available or currently underway. However, no systematic reviews have been conducted on opioids for procedural pain.…”

Section: Why It Is Important To Do This Reviewmentioning

confidence: 99%

Opioids for procedural pain in neonates

Kinoshita

Olsson

Borys

et al. 2023

Cochrane Database of Systematic Reviews

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Pharmacological interventions for pain and sedation management in newborn infants undergoing therapeutic hypothermia

Cited by 8 publications

References 64 publications

Continuous Fentanyl Infusion in Newborns with Hypoxic–Ischemic Encephalopathy Treated with Therapeutic Hypothermia: Background, Aims, and Study Protocol for Time-Concentration Profiles

Continuous Fentanyl Infusion in Newborns with Hypoxic–Ischemic Encephalopathy Treated with Therapeutic Hypothermia: Background, Aims, and Study Protocol for Time-Concentration Profiles

Interventions for the Management of Pain and Sedation in Newborns Undergoing Therapeutic Hypothermia for Hypoxic-Ischemic Encephalopathy: A Systematic Review

Opioids for procedural pain in neonates

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