TABLE 2

Selected Related Clinical Effects and Duration of Clinical Effects Observed Among Children 19 Years Old and Younger Exposed to a Single Buprenorphine Product by Age Group, NPDS 2007–2016

Characteristics<6 y, n (%)6–12 y, n (%)13–19 y, n (%)Total, n (%)
Total single-substance exposures935830790510 570
Selected related clinical effectsa
 Neurologic
  Drowsiness and/or lethargy4568 (48.8)103 (33.6)277 (30.6)4948 (46.8)
  Agitated and/or irritable346 (3.7)2 (0.7)21 (2.3)369 (3.5)
  Ataxia330 (3.5)5 (1.6)16 (1.8)351 (3.3)
  Dizziness and/or vertigo66 (0.7)30 (9.8)72 (8.0)168 (1.6)
  Confusion51 (0.5)5 (1.6)22 (2.4)78 (0.7)
  Coma51 (0.5)0 (0.0)14 (1.5)65 (0.6)
  Slurred speech39 (0.4)3 (1.0)18 (2.0)60 (0.6)
  Seizure (single or multiple)6 (0.1)1 (0.3)3 (0.3)10 (0.1)
  Hallucinations and/or delusions3 (0.0)1 (0.3)4 (0.4)8 (0.1)
  Syncope5 (0.1)0 (0.0)6 (0.7)11 (0.1)
 Gastrointestinal
  Vomiting1463 (15.6)63 (20.5)273 (30.2)1799 (17.0)
  Nausea184 (2.0)42 (13.7)161 (17.8)387 (3.7)
 Ocular
  Miosis1279 (13.7)26 (8.5)32 (3.5)1337 (12.6)
  Pupil(s) nonreactive11 (0.1)0 (0.0)0 (0.0)11 (0.1)
 Respiratory
  Respiratory depression852 (9.1)15 (4.9)24 (2.7)891 (8.4)
  Cyanosis35 (0.4)0 (0.0)1 (0.1)36 (0.3)
  Dyspnea27 (0.3)0 (0.0)7 (0.8)34 (0.3)
  Respiratory arrest22 (0.2)0 (0.0)1 (0.1)23 (0.2)
 Cardiovascular
  Tachycardia149 (1.6)4 (1.3)44 (4.9)197 (1.9)
  Hypotension99 (1.1)0 (0.0)6 (0.7)105 (1.0)
  Bradycardia82 (0.9)3 (1.0)13 (1.4)98 (0.9)
  Hypertension19 (0.2)0 (0.0)12 (1.3)31 (0.3)
  Cardiac arrest5 (0.1)0 (0.0)1 (0.1)6 (0.1)
  Conduction disturbance3 (0.0)0 (0.0)1 (0.1)4 (0.0)
Clinical effects durationb
 ≤2 h375 (6.9)15 (9.3)35 (5.6)425 (6.8)
 >2, ≤8 h1363 (25.0)34 (21.0)151 (24.2)1548 (24.8)
 >8, ≤24 h2649 (48.6)70 (43.2)156 (25.0)2875 (46.1)
 >24 h, ≤3 d504 (9.2)11 (6.8)31 (5.0)546 (8.7)
 >3 d43 (0.8)1 (0.6)5 (0.8)49 (0.8)
 Unknown or missing522 (9.6)31 (19.2)245 (39.4)798 (12.7)
Subtotal54561626236241
  • a Percentages for selected related clinical effects were calculated by using the study’s total number of single-substance exposures as the denominator and may sum to >100.0% because some exposures may result in ˃1 related clinical effect.

  • b Percentages were calculated by using only cases with at least 1 related clinical effect and may not sum to 100.0% because of rounding error.