[Efficacy of the EMLA cream in the reduction of pain caused by venipuncture in children premedicated with oral midazolam].
OBJECTIVE
EMLA cream, a lidocaine-prilocaine mixture, penetrates skin easily. Our aim was to compare EMLA and placebo to assess the efficacy of EMLA in decreasing the pain of venipuncture in children premedicated with oral midazolam 0.5 mg/kg.


METHODS
This was a prospective study enrolling 100 children 3 to 9 years of age (5.6 +/- 2) randomly distributed in 2 groups of 50. EMLA cream was applied in group 1 while placebo was applied in group 2 (control group). All were premedicated with oral midazolam. Either EMLA or placebo was applied at least 30 minutes before transfer to the operating theater and the area was covered with a transparent dressing. Parameters recorded upon arrival in the operating room and upon hand puncture with a 22-G needle were systolic and diastolic arterial pressures (SAP and DAP) and heart rate (HR). Pain was assessed on a behavior scale, a visual analog scale evaluated by the anesthesiologist (VAS-anesthesiologist) and a VAS evaluated by a nurse (VAS-nurse). Adverse events were also recorded. A Student t-test and a Mann-Whitney U-test were used for statistical analysis; the level of significance was p < 0.05.


RESULTS
There were no significant differences in mean age or weight between the 2 groups. In the area EMLA was applied, 2 children presented erythema and 2 pruritus. Mean scores on the pain scales were lower in the EMLA group (p < 0.05) than in the control group: behavior scale 1.8 +/- 1.3 versus 3.2 +/- 1.7; VAS-anesthesiologist 2.8 +/- 2.3 versus 5.1 +/- 2.7; VAS-nurse 2.7 +/- 2.1 versus 5.9 +/- 1.9. HR increased in both groups (with placebo from 105 +/- 16 to 118 +/- 19, and with EMLA from 99 +/- 19 to 109 +/- 21), but the increase in SAP was statistically significant only in the placebo group, in which it rose from 113 +/- 11 to 125 +/- 16.


CONCLUSIONS
EMLA cream decreases the pain of hand venipuncture in children premedicated with oral midazolam.
Cassinello
F
F
Servico de Anestesiología y Reanimación, Hospital del Niño Jesús, Madrid.
Martín-Celemín
R
R
Herrero
E
E
Palencia
J
J
de Stefano
J
J
Pérez-Gallardo
A
A
D000759:Adjuvants, Anesthesia / Q000008:administration & dosage; D000284:Administration, Oral; D000779:Anesthetics, Local; D002648:Child; D002675:Child, Preschool; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008012:Lidocaine; D000077442:Lidocaine, Prilocaine Drug Combination; D008297:Male; D008874:Midazolam / Q000008:administration & dosage; D010146:Pain / Q000209:etiology / Q000517:prevention & control*; D018962:Phlebotomy / Q000009:adverse effects*; D011229:Preanesthetic Medication; D011318:Prilocaine; D011446:Prospective Studies
D000759:Adjuvants, Anesthesia; D000779:Anesthetics, Local; D004338:Drug Combinations; D000077442:Lidocaine, Prilocaine Drug Combination; D011318:Prilocaine; D008012:Lidocaine; D008874:Midazolam