Table 3.

Safety Studies With EMLA in Neonates

ReferenceProcedureGestational
Age at
Birth (wk)
Number
Exposed
Dosage RegimenSampling
Time (h)
%
MetHb*
(mean, SD)
Law24Circumcision35–41101.0 g for 60–80 min80.44 (0.53)
Taddio8Circumcision37–42381.0 g for 60 min1–181.3 (0.6)
Lander9CircumcisionFull-term132.0 g for 90 minnr(range, 0–4.5)
Ramaioli10Heel lancing29–36100.5 g (=1 cm) for 30 min0.50.6 (0.2)
Ramaioli20Heel lancingFull-term151 g for 30 min0.50.85 (0.2)
Taddio23Heel lancing30–37260.5 g for 30 min81.3 (0.5)
Taddio22Heel lancing30–37300.5 g for 60 min4–121.3 (0.3)
Enad14Lumbar puncture≥34nr1.0 g for 60 min40.85 (0.84)
Garcia15Percutaneous
venous catheter
placement
Very low
birth weight
71.25 g for 60 minnr(range, 0.3–2.0)
Andreasson20VenipunctureFull-term
(0–3 months)
nr1 g for 60–70 min0.5–18(range, 0.5–2.5)
Rubio6Needle insertion29 ± 2.5480.5–1 g for 30–40 min80.68 (0.55)
Gourrier2526nr26–41158≥2 kg: 1/4 tube (≈0.5 g)
<2 kg: nr for 60–180 min
nr(range, 0.4–6.2)
  • * MetHb levels were reported as a percentage of hemoglobin in all studies. The mean (SD) or range, is reported.

  • Published in abstract form only.

  • nr, not reported.