Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation
Dexmedetomidine (Precedex™) may be used as an alternative sedative in children, maintaining spontaneous breathing, and avoiding tracheal intubation in a non-intubated moderate or deep sedation (NI-MDS) approach. This open-label, single-arm, multicenter study evaluated the safety of dexmedetomidine i...
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Frontiers Media S.A.
2017-08-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | http://journal.frontiersin.org/article/10.3389/fphar.2017.00529/full |
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| author | Edmund H. Jooste Gregory B. Hammer Christian R. Reyes Vaibhav Katkade Peter Szmuk Peter Szmuk |
| author_facet | Edmund H. Jooste Gregory B. Hammer Christian R. Reyes Vaibhav Katkade Peter Szmuk Peter Szmuk |
| author_sort | Edmund H. Jooste |
| collection | DOAJ |
| description | Dexmedetomidine (Precedex™) may be used as an alternative sedative in children, maintaining spontaneous breathing, and avoiding tracheal intubation in a non-intubated moderate or deep sedation (NI-MDS) approach. This open-label, single-arm, multicenter study evaluated the safety of dexmedetomidine in a pediatric population receiving NI-MDS in an operating room or a procedure room, with an intensivist or anesthesiologist in attendance, for elective diagnostic or therapeutic procedures expected to take at least 30 min. The primary endpoint was incidence of treatment-emergent adverse events (TEAEs). Patients received one of two doses dependent on age: patients aged ≥28 weeks' gestational age to <1 month postnatal received dose level 1 (0.1 μg/kg load; 0.05–0.2 μg/kg/h infusion); those aged 1 month to <17 years received dose level 2 (1 μg/kg load; 0.2–2.0 μg/kg/h infusion). Sedation efficacy was assessed and defined as adequate sedation for at least 80% of the time and successful completion of the procedure without the need for rescue medication. In all, 91 patients were enrolled (dose level 1, n = 1; dose level 2, n = 90); of these, 90 received treatment and 82 completed the study. Eight patients in dose level 2 discontinued treatment for the following reasons: early completion of diagnostic or therapeutic procedure (n = 3); change in medical condition (need for intubation) requiring deeper level of sedation (n = 2); adverse event (AE; hives and emesis), lack of efficacy, and physician decision (patient not sedated enough to complete procedure; n = 1 each). Sixty-seven patients experienced 147 TEAEs. The two most commonly reported AEs were respiratory depression (bradypnea; reported per protocol-defined criteria, based on absolute respiratory rate values for age or relative decrease of 30% from baseline) and hypotension. Four patients received glycopyrrolate for bradycardia and seven patients received intravenous fluids for hypotension. SpO2 dropped by 10% in two patients, but resolved without need for manual ventilation. All other reported AEs were consistent with the known safety profile of dexmedetomidine. Two of the 78 patients in the efficacy-evaluable population met all sedation efficacy criteria. Dexmedetomidine was well-tolerated in pediatric patients undergoing procedure-type sedation. |
| first_indexed | 2024-12-21T13:38:23Z |
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| id | doaj.art-9412a6363580465a8646398b1189e987 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-12-21T13:38:23Z |
| publishDate | 2017-08-01 |
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| spelling | doaj.art-9412a6363580465a8646398b1189e9872022-12-21T19:02:06ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122017-08-01810.3389/fphar.2017.00529275831Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type SedationEdmund H. Jooste0Gregory B. Hammer1Christian R. Reyes2Vaibhav Katkade3Peter Szmuk4Peter Szmuk5Pediatric Cardiac Anesthesiology, Duke Children's Hospital and Health CenterDurham, NC, United StatesDepartments of Anesthesiology, Perioperative and Pain Medicine and Pediatrics, Stanford University School of MedicineStanford, CA, United StatesDepartment of Biostatistics, PfizerManila, PhilippinesDepartment of Medical Affairs, PfizerCollegeville, PA, United StatesDepartment of Anesthesiology and Pain Medicine, Children's Health Medical Center, University of Texas Southwestern Medical CenterDallas, TX, United StatesOutcomes Research ConsortiumCleveland, OH, United StatesDexmedetomidine (Precedex™) may be used as an alternative sedative in children, maintaining spontaneous breathing, and avoiding tracheal intubation in a non-intubated moderate or deep sedation (NI-MDS) approach. This open-label, single-arm, multicenter study evaluated the safety of dexmedetomidine in a pediatric population receiving NI-MDS in an operating room or a procedure room, with an intensivist or anesthesiologist in attendance, for elective diagnostic or therapeutic procedures expected to take at least 30 min. The primary endpoint was incidence of treatment-emergent adverse events (TEAEs). Patients received one of two doses dependent on age: patients aged ≥28 weeks' gestational age to <1 month postnatal received dose level 1 (0.1 μg/kg load; 0.05–0.2 μg/kg/h infusion); those aged 1 month to <17 years received dose level 2 (1 μg/kg load; 0.2–2.0 μg/kg/h infusion). Sedation efficacy was assessed and defined as adequate sedation for at least 80% of the time and successful completion of the procedure without the need for rescue medication. In all, 91 patients were enrolled (dose level 1, n = 1; dose level 2, n = 90); of these, 90 received treatment and 82 completed the study. Eight patients in dose level 2 discontinued treatment for the following reasons: early completion of diagnostic or therapeutic procedure (n = 3); change in medical condition (need for intubation) requiring deeper level of sedation (n = 2); adverse event (AE; hives and emesis), lack of efficacy, and physician decision (patient not sedated enough to complete procedure; n = 1 each). Sixty-seven patients experienced 147 TEAEs. The two most commonly reported AEs were respiratory depression (bradypnea; reported per protocol-defined criteria, based on absolute respiratory rate values for age or relative decrease of 30% from baseline) and hypotension. Four patients received glycopyrrolate for bradycardia and seven patients received intravenous fluids for hypotension. SpO2 dropped by 10% in two patients, but resolved without need for manual ventilation. All other reported AEs were consistent with the known safety profile of dexmedetomidine. Two of the 78 patients in the efficacy-evaluable population met all sedation efficacy criteria. Dexmedetomidine was well-tolerated in pediatric patients undergoing procedure-type sedation.http://journal.frontiersin.org/article/10.3389/fphar.2017.00529/fullalpha2 agonistdexmedetomidinenon-intubatedpediatricsedationNCT01519167; https://clinicaltrials.gov/ct2/show/NCT01519167 |
| spellingShingle | Edmund H. Jooste Gregory B. Hammer Christian R. Reyes Vaibhav Katkade Peter Szmuk Peter Szmuk Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation Frontiers in Pharmacology alpha2 agonist dexmedetomidine non-intubated pediatric sedation NCT01519167; https://clinicaltrials.gov/ct2/show/NCT01519167 |
| title | Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation |
| title_full | Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation |
| title_fullStr | Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation |
| title_full_unstemmed | Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation |
| title_short | Phase IV, Open-Label, Safety Study Evaluating the Use of Dexmedetomidine in Pediatric Patients Undergoing Procedure-Type Sedation |
| title_sort | phase iv open label safety study evaluating the use of dexmedetomidine in pediatric patients undergoing procedure type sedation |
| topic | alpha2 agonist dexmedetomidine non-intubated pediatric sedation NCT01519167; https://clinicaltrials.gov/ct2/show/NCT01519167 |
| url | http://journal.frontiersin.org/article/10.3389/fphar.2017.00529/full |
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