OBJECTIVE: A number of studies have shown that orally administered sweet-tasting solutions reduce signs of pain during painful procedures. The local anesthetic creamEMLA has recently been shown to be safe for use in neonates. This study compared the pain-reducing effect of orally administered glucose with that of EMLA cream during venipuncture in newborns. METHODS: Randomized, controlled, double-blind study including 201 newborns undergoing venipuncture for clinical purposes. Ninety-nine of the newborns received EMLA on the skin and orally administered placebo (sterile water), and 102 received glucose 30% orally and placebo (Unguentum Merck) on the skin. Symptoms associated with pain at venipuncture were measured with the Premature Infant Pain Profile (PIPP) scale (also validated for full-term infants). Heart rate and crying time were recorded. RESULTS: There were no differences in background variables between the 2 groups. The results shows that the PIPP scores were significantly lower in the glucose group (mean: 4.6) compared with the EMLA group (mean: 5.7). The duration of crying in the first 3 minutes was significantly lower in the glucose group (median: 1 second) than in the EMLA group (median: 18 seconds). There were significantly fewer patients in the glucose group who were scored having pain (defined as PIPP score above 6); 19.3% compared with 41.7% in the EMLA group. The changes in heart rate were similar in both groups. CONCLUSIONS: We found that glucose is effective in reducing symptoms associated with pain from venipuncture in newborns and seems to be better than the local anesthetic creamEMLA.
RCT Entities:
OBJECTIVE: A number of studies have shown that orally administered sweet-tasting solutions reduce signs of pain during painful procedures. The local anesthetic cream EMLA has recently been shown to be safe for use in neonates. This study compared the pain-reducing effect of orally administered glucose with that of EMLA cream during venipuncture in newborns. METHODS: Randomized, controlled, double-blind study including 201 newborns undergoing venipuncture for clinical purposes. Ninety-nine of the newborns received EMLA on the skin and orally administered placebo (sterile water), and 102 received glucose 30% orally and placebo (Unguentum Merck) on the skin. Symptoms associated with pain at venipuncture were measured with the Premature InfantPain Profile (PIPP) scale (also validated for full-term infants). Heart rate and crying time were recorded. RESULTS: There were no differences in background variables between the 2 groups. The results shows that the PIPP scores were significantly lower in the glucose group (mean: 4.6) compared with the EMLA group (mean: 5.7). The duration of crying in the first 3 minutes was significantly lower in the glucose group (median: 1 second) than in the EMLA group (median: 18 seconds). There were significantly fewer patients in the glucose group who were scored having pain (defined as PIPP score above 6); 19.3% compared with 41.7% in the EMLA group. The changes in heart rate were similar in both groups. CONCLUSIONS: We found that glucose is effective in reducing symptoms associated with pain from venipuncture in newborns and seems to be better than the local anesthetic cream EMLA.