A multicenter study to evaluate the pharmacokinetics and safety of liposomal bupivacaine for postsurgical analgesia in pediatric patients aged 6 to less than 17 years (PLAY) - 13/11/21
, Alberto J. de Armendi b, Nicole D. Horn c, Gregory B. Hammer d, Michal Szczodry e, Maria Matuszczak f, Natalie Q. Wang g, Richard Scranton h, Robert Tracy Ballock iAbstract |
Study objective |
To evaluate the pharmacokinetics and safety of liposomal bupivacaine in pediatric patients undergoing spine or cardiac surgery.
Design |
Multicenter, open-label, phase 3, randomized trial (PLAY; NCT03682302).
Setting |
Operating room.
Patients |
Two separate age groups were evaluated (age group 1: patients 12 to <17 years undergoing spine surgery; age group 2: patients 6 to <12 years undergoing spine or cardiac surgery).
Intervention |
Randomized allocation of liposomal bupivacaine 4 mg/kg or bupivacaine hydrochloride (HCl) 2 mg/kg via local infiltration at the end of spine surgery (age group 1); liposomal bupivacaine 4 mg/kg via local infiltration at the end of spine or cardiac surgery (age group 2).
Measurements |
The primary and secondary objectives were to evaluate the pharmacokinetics (eg, maximum plasma bupivacaine concentrations [Cmax], time to Cmax) and safety of liposomal bupivacaine, respectively.
Main results |
Baseline characteristics were comparable across groups. Mean Cmax after liposomal bupivacaine administration was lower versus bupivacaine HCl in age group 1 (357 vs 564 ng/mL); mean Cmax in age group 2 was 320 and 447 ng/mL for spine and cardiac surgery, respectively. Median time to Cmax of liposomal bupivacaine occurred later with cardiac surgery versus spine surgery (22.7 vs 7.4 h). In age group 1, the incidence of adverse events (AEs) was comparable between liposomal bupivacaine (61% [19/31]) and bupivacaine HCl (73% [22/30]). In age group 2, 100% (5/5) and 31% (9/29) of patients undergoing spine and cardiac surgery experienced AEs, respectively. AEs were generally mild or moderate, with no discontinuations due to AEs or deaths.
Conclusions |
Plasma bupivacaine levels following local infiltration with liposomal bupivacaine remained below the toxic threshold in adults (~2000–4000 ng/mL) across age groups and procedures. AEs were mild to moderate, supporting the safety of liposomal bupivacaine in pediatric patients undergoing spine or cardiac surgery.
Clinical trial number and registry URL: ClinicalTrials.gov identifier: NCT03682302
Le texte complet de cet article est disponible en PDF.Graphical abstract |
Highlights |
• | The pharmacokinetics and safety of LB were characterized in pediatric patients. |
• | Plasma bupivacaine concentrations after LB remained below toxicity thresholds. |
• | Adverse events with LB were generally mild to moderate in severity. |
• | This phase 3 study suggested LB is safe and tolerable in pediatric patients. |
Keywords : Pediatrics, Anesthesia, Bupivacaine, Pharmacokinetics, Analgesia, Cardiac surgical procedures
Plan
| ☆ | Part of the work presented in this article has been presented at the virtual ANESTHESIOLOGY® 2020 Annual Meeting, October 3, 2020. |
Vol 75
Article 110503- décembre 2021 Retour au numéro
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