Clonidine for sedation in infants during therapeutic hypothermia with neonatal encephalopathy: pilot study

Gauda, Estelle B.; Chavez‐Valdez, Raul; Northington, Frances J.; Lee, Carlton K. K.; Rudek, Michelle A.; Guglieri-López, Beatriz; Ivaturi, Vijay

doi:10.1038/s41372-021-01151-1

Cited by 4 publications

(5 citation statements)

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“…Randomized controlled studies are under way ( 55 ). Other alternatives such as clonidine might be beneficial ( 57 ). Recent new proposals for guidelines stress also the fundamental importance of non-pharmacologic strategies, the avoidance of benzodiazepine, and a reduced use of opioids, potentially with the alternative dexmedetomidine ( 58 ).…”

Section: Discussionmentioning

confidence: 99%

Adequacy of sedation analgesia to support the comfort of neonates undergoing therapeutic hypothermia and its impact on short-term neonatal outcomes

et al. 2023

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ObjectivesWe aimed to evaluate (1) whether sedation analgesia (SA) used during therapeutic hypothermia (TH) was efficient to support the wellbeing of neonates with hypoxic-ischemic encephalopathy, (2) the SA level and its adjustment to clinical pain scores, and (3) the impact of inadequate SA on short-term neonatal outcomes evaluated at discharge.MethodsThis was an observational retrospective study performed between 2011 and 2018 in two level III centers in Alsace, France. We analyzed the wellbeing of infants by using the COMFORT-Behavior (COMFORT-B) clinical score and SA level during TH, according to which we classified infants into four groups: those with excess SA, adequate SA, lack of SA, and variability of SA. We analyzed the variations in doses of SA and their justification. We also determined the impact of inadequate SA on neonatal outcomes at discharge by multivariate analyses with multinomial regression, with adequate SA as the reference.ResultsA total of 110 patients were included, 89 from Strasbourg university hospital and 21 from Mulhouse hospital. The COMFORT-B score was assessed 95.5% of the time. Lack of SA was mainly found on the first day of TH (15/110, 14%). In all, 62 of 110 (57%) infants were in excess of SA over the entire duration of TH. Most dose variations were related to clinical pain scores. Inadequate SA was associated with negative short-term consequences. Infants with excess of SA had a longer duration of mechanical ventilation [mean ratio 1.46, 95% confidence interval (CI), 1.13–1.89, p = 0.005] and higher incidence of abnormal neurological examination at discharge (odds ratio 2.61, 95% CI, 1.10–6.18, p = 0.029) than infants with adequate SA.DiscussionAdequate SA was not easy to achieve during TH. Close and regular monitoring of SA level may help achieve adequate SA. Excess of SA can be harmful for newborns with hypoxic-ischemic encephalopathy who are undergoing TH.

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Section: Discussionmentioning

confidence: 99%

Adequacy of sedation analgesia to support the comfort of neonates undergoing therapeutic hypothermia and its impact on short-term neonatal outcomes

et al. 2023

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“…Clonidine. Intravenous Clonidine at a dose of 1 μg/kg every 8h administered over 30 mins during TH was reported as safe along with less opiate needs for shivering and agitation [67]. In contrary to population pharmacokinetic models derived from term neonates with a narcotic withdrawal syndrome, during TH the clearance of clonidine was reduced by 22% and volume of distribution was reduced by 28% [67].…”

Section: Plos Onementioning

confidence: 98%

“…Gauda et al compared a historical cohort of hypothermic neonates who received morphine only, with neonates who received Clonidine every 8 hours during TH spent lesser time above the target temperature. Moreover, during the rewarming phase, neonates treated with Clonidine took 48% longer time to reach normal temperature (9h) versus controls (6h) [67].…”

Section: Plos Onementioning

confidence: 99%

“…Intravenous Clonidine at a dose of 1 μg/kg every 8h administered over 30 mins during TH was reported as safe along with less opiate needs for shivering and agitation [67]. In contrary to population pharmacokinetic models derived from term neonates with a narcotic withdrawal syndrome, during TH the clearance of clonidine was reduced by 22% and volume of distribution was reduced by 28% [67]. Gauda et al compared a historical cohort of hypothermic neonates who received morphine only, with neonates who received Clonidine every 8 hours during TH spent lesser time above the target temperature.…”

Section: Plos Onementioning

confidence: 99%

“…Nine studies reported the pharmacokinetic profiles of common medications used for sedation and analgesia in neonates during TH [30,36,37,[63][64][65][66][67][68]. Midazolam was studied in three studies, morphine in four studies, alpha2-agonist in two studies, and melatonin in one study (Table 4).…”

Section: Question 3 What Is the Extent Of Knowledge Regarding Alterat...mentioning

confidence: 99%

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Analgesia and sedation strategies in neonates undergoing whole-body therapeutic hypothermia: A scoping review

Joshi,

Muneer,

Mbuagbaw

et al. 2023

PLoS ONE

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Background Therapeutic hypothermia (TH) is a widely practiced neuroprotective strategy for neonates with hypoxic-ischemic encephalopathy. Induced hypothermia is associated with shivering, cold pain, agitation, and distress. Objective This scoping review determines the breadth of research undertaken for pain and stress management in neonates undergoing hypothermia therapy, the pharmacokinetics of analgesic and sedative medications during hypothermia and the effect of such medication on short- and long-term neurological outcomes. Methods We searched the following online databases namely, (i) MEDLINE, (ii) Web of Science, (iii) Cochrane Library, (iv) Scopus, (v) CINAHL, and (vi) EMBASE to identify published original articles between January 2005 and December 2022. We included only English full-text articles on neonates treated with TH and reported the sedation/analgesia strategy used. We excluded articles that reported TH on transport or extracorporeal membrane oxygenation, did not report the intervention strategies for sedation/analgesia, and reported hypoxic-ischemic encephalopathy in which hypothermia was not applied. Results The eligible publications (n = 97) included cohort studies (n = 72), non-randomized experimental studies (n = 2), pharmacokinetic studies (n = 4), dose escalation feasibility trial (n = 1), cross-sectional surveys (n = 5), and randomized control trials (n = 13). Neonatal Pain, Agitation, and Sedation Scale (NPASS) is the most frequently used pain assessment tool in this cohort. The most frequently used pharmacological agents are opioids (Morphine, Fentanyl), benzodiazepine (Midazolam) and Alpha2 agonists (Dexmedetomidine). The proportion of neonates receiving routine sedation-analgesia during TH is center-specific and varies from 40–100% worldwide. TH alters most drugs’ metabolic rate and clearance, except for Midazolam. Dexmedetomidine has additional benefits of thermal tolerance, neuroprotection, faster recovery, and less likelihood of seizures. There is a wide inter-individual variability in serum drug levels due to the impact of temperature, end-organ dysfunction, postnatal age, and body weight on drug metabolism. Conclusions No multidimensional pain scale has been tested for reliability and construct validity in hypothermic encephalopathic neonates. There is an increasing trend towards using routine sedation/analgesia during TH worldwide. Wide variability in the type of medication used, administration (bolus versus infusion), and dose ranges used emphasizes the urgent need for standardized practice recommendations and guidelines. There is insufficient data on the long-term neurological outcomes of exposure to these medications, adjusted for underlying brain injury and severity of encephalopathy. Future studies will need to develop framework tools to enable precise control of sedation/analgesia drug exposure customized to individual patient needs.

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Oral Clonidine-Based Strategy to Reduce Opiate Use During Cooling for Neonatal Encephalopathy: An Observational Study

Fribance,

Liang,

Lee

et al. 2024

The Journal of Pediatrics

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Clonidine for sedation in infants during therapeutic hypothermia with neonatal encephalopathy: pilot study

Cited by 4 publications

References 46 publications

Adequacy of sedation analgesia to support the comfort of neonates undergoing therapeutic hypothermia and its impact on short-term neonatal outcomes

Adequacy of sedation analgesia to support the comfort of neonates undergoing therapeutic hypothermia and its impact on short-term neonatal outcomes

Analgesia and sedation strategies in neonates undergoing whole-body therapeutic hypothermia: A scoping review

Oral Clonidine-Based Strategy to Reduce Opiate Use During Cooling for Neonatal Encephalopathy: An Observational Study

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