PubMed:23582138 JSONTXT

{"project":"Allie","denotations":[{"id":"SS1_23582138_5_0","span":{"begin":686,"end":737},"obj":"expanded"},{"id":"SS2_23582138_5_0","span":{"begin":1007,"end":1011},"obj":"abbr"}],"relations":[{"id":"AE1_23582138_5_0","pred":"abbreviatedTo","subj":"SS1_23582138_5_0","obj":"SS2_23582138_5_0"}],"text":"Efficacy and safety of continuous infusion of fentanyl for pain control in preterm newborns on mechanical ventilation.\nOBJECTIVE: To evaluate the analgesic superiority and the safety equivalence of continuous fentanyl infusions versus fentanyl boluses in preterm infants on mechanical ventilation.\nSTUDY DESIGN: In this multicenter, double-blind, randomized controlled trial, mechanically ventilated newborns (≤ 32(+6) weeks gestational age) were randomized to fentanyl (continuous infusion of fentanyl plus open-label boluses of fentanyl) or placebo (continuous infusion of placebo plus open-label boluses of fentanyl). The primary endpoint was analgesic efficacy, as evaluated by the Echelle Douleur Inconfort Nouveau-Né (EDIN) and Premature Infant Pain Profile scales. Safety variables were evaluated as well.\nRESULTS: Sixty-four infants were allocated to the fentanyl group, and 67 were allocated to the placebo group. The need for open-label boluses of fentanyl was similar in the 2 groups (P = .949). EDIN scores were comparable in the 2 groups; 65 of 961 (6.8%) EDIN scores were \u003e6 in the fentanyl group and 91 of 857 (10.6%) in the placebo group (P = .003). The median Premature Infant Pain Profile score was clinically and statistically higher in the placebo group compared with the fentanyl group on days 1, 2, and 3 of treatment (P \u003c .05). Mechanical ventilation at age 1 week was required in 27 of 64 infants in the fentanyl group (42.2%), compared with 17 of 67 infants in the placebo group (25.4%) (P = .042). The first cycle of mechanical ventilation was longer and the first meconium passage occurred later in the fentanyl group (P = .019 and .027, respectively).\nCONCLUSION: In very preterm infants on mechanical ventilation, continuous fentanyl infusion plus open-label boluses of fentanyl does not reduce prolonged pain, but does reduce acute pain and increase side effects compared with open-label boluses of fentanyl alone."}

{"project":"PCI_RCT","denotations":[{"id":"T1","span":{"begin":75,"end":91},"obj":"DP"},{"id":"T2","span":{"begin":46,"end":54},"obj":"CI"},{"id":"T3","span":{"begin":209,"end":217},"obj":"CI"},{"id":"T4","span":{"begin":235,"end":243},"obj":"CI"},{"id":"T5","span":{"begin":461,"end":469},"obj":"CI"},{"id":"T6","span":{"begin":543,"end":550},"obj":"CI"},{"id":"T7","span":{"begin":530,"end":538},"obj":"CI"},{"id":"T8","span":{"begin":494,"end":502},"obj":"CI"},{"id":"T9","span":{"begin":610,"end":618},"obj":"CI"},{"id":"T10","span":{"begin":863,"end":871},"obj":"CI"},{"id":"T11","span":{"begin":958,"end":966},"obj":"CI"},{"id":"T12","span":{"begin":1292,"end":1300},"obj":"CI"},{"id":"T13","span":{"begin":1260,"end":1267},"obj":"CI"},{"id":"T14","span":{"begin":1428,"end":1436},"obj":"CI"},{"id":"T15","span":{"begin":1096,"end":1104},"obj":"CI"},{"id":"T16","span":{"begin":1630,"end":1638},"obj":"CI"},{"id":"T17","span":{"begin":1754,"end":1762},"obj":"CI"},{"id":"T18","span":{"begin":1799,"end":1807},"obj":"CI"},{"id":"T19","span":{"begin":1929,"end":1937},"obj":"CI"},{"id":"T20","span":{"begin":575,"end":582},"obj":"CI"},{"id":"T21","span":{"begin":908,"end":915},"obj":"CI"},{"id":"T22","span":{"begin":1140,"end":1147},"obj":"CI"},{"id":"T23","span":{"begin":1490,"end":1497},"obj":"CI"}],"text":"Efficacy and safety of continuous infusion of fentanyl for pain control in preterm newborns on mechanical ventilation.\nOBJECTIVE: To evaluate the analgesic superiority and the safety equivalence of continuous fentanyl infusions versus fentanyl boluses in preterm infants on mechanical ventilation.\nSTUDY DESIGN: In this multicenter, double-blind, randomized controlled trial, mechanically ventilated newborns (≤ 32(+6) weeks gestational age) were randomized to fentanyl (continuous infusion of fentanyl plus open-label boluses of fentanyl) or placebo (continuous infusion of placebo plus open-label boluses of fentanyl). The primary endpoint was analgesic efficacy, as evaluated by the Echelle Douleur Inconfort Nouveau-Né (EDIN) and Premature Infant Pain Profile scales. Safety variables were evaluated as well.\nRESULTS: Sixty-four infants were allocated to the fentanyl group, and 67 were allocated to the placebo group. The need for open-label boluses of fentanyl was similar in the 2 groups (P = .949). EDIN scores were comparable in the 2 groups; 65 of 961 (6.8%) EDIN scores were \u003e6 in the fentanyl group and 91 of 857 (10.6%) in the placebo group (P = .003). The median Premature Infant Pain Profile score was clinically and statistically higher in the placebo group compared with the fentanyl group on days 1, 2, and 3 of treatment (P \u003c .05). Mechanical ventilation at age 1 week was required in 27 of 64 infants in the fentanyl group (42.2%), compared with 17 of 67 infants in the placebo group (25.4%) (P = .042). The first cycle of mechanical ventilation was longer and the first meconium passage occurred later in the fentanyl group (P = .019 and .027, respectively).\nCONCLUSION: In very preterm infants on mechanical ventilation, continuous fentanyl infusion plus open-label boluses of fentanyl does not reduce prolonged pain, but does reduce acute pain and increase side effects compared with open-label boluses of fentanyl alone."}

{"project":"chenxin_473849_800_3","denotations":[{"id":"T1","span":{"begin":1799,"end":1807},"obj":"CI"},{"id":"T2","span":{"begin":46,"end":54},"obj":"CI"},{"id":"T3","span":{"begin":209,"end":217},"obj":"CI"},{"id":"T4","span":{"begin":235,"end":243},"obj":"CI"},{"id":"T5","span":{"begin":461,"end":469},"obj":"CI"},{"id":"T6","span":{"begin":494,"end":502},"obj":"CI"},{"id":"T7","span":{"begin":530,"end":538},"obj":"CI"},{"id":"T8","span":{"begin":610,"end":618},"obj":"CI"},{"id":"T9","span":{"begin":863,"end":871},"obj":"CI"},{"id":"T10","span":{"begin":958,"end":966},"obj":"CI"},{"id":"T11","span":{"begin":1096,"end":1104},"obj":"CI"},{"id":"T12","span":{"begin":1292,"end":1300},"obj":"CI"},{"id":"T13","span":{"begin":1428,"end":1436},"obj":"CI"},{"id":"T14","span":{"begin":1630,"end":1638},"obj":"CI"},{"id":"T15","span":{"begin":1754,"end":1762},"obj":"CI"},{"id":"T16","span":{"begin":1929,"end":1937},"obj":"CI"},{"id":"T17","span":{"begin":543,"end":550},"obj":"CI"},{"id":"T18","span":{"begin":575,"end":582},"obj":"CI"},{"id":"T19","span":{"begin":908,"end":915},"obj":"CI"},{"id":"T20","span":{"begin":1140,"end":1147},"obj":"CI"},{"id":"T21","span":{"begin":1260,"end":1267},"obj":"CI"},{"id":"T22","span":{"begin":1490,"end":1497},"obj":"CI"},{"id":"T23","span":{"begin":75,"end":91},"obj":"DP"},{"id":"T24","span":{"begin":255,"end":270},"obj":"DP"},{"id":"T25","span":{"begin":1700,"end":1715},"obj":"DP"}],"text":"Efficacy and safety of continuous infusion of fentanyl for pain control in preterm newborns on mechanical ventilation.\nOBJECTIVE: To evaluate the analgesic superiority and the safety equivalence of continuous fentanyl infusions versus fentanyl boluses in preterm infants on mechanical ventilation.\nSTUDY DESIGN: In this multicenter, double-blind, randomized controlled trial, mechanically ventilated newborns (≤ 32(+6) weeks gestational age) were randomized to fentanyl (continuous infusion of fentanyl plus open-label boluses of fentanyl) or placebo (continuous infusion of placebo plus open-label boluses of fentanyl). The primary endpoint was analgesic efficacy, as evaluated by the Echelle Douleur Inconfort Nouveau-Né (EDIN) and Premature Infant Pain Profile scales. Safety variables were evaluated as well.\nRESULTS: Sixty-four infants were allocated to the fentanyl group, and 67 were allocated to the placebo group. The need for open-label boluses of fentanyl was similar in the 2 groups (P = .949). EDIN scores were comparable in the 2 groups; 65 of 961 (6.8%) EDIN scores were \u003e6 in the fentanyl group and 91 of 857 (10.6%) in the placebo group (P = .003). The median Premature Infant Pain Profile score was clinically and statistically higher in the placebo group compared with the fentanyl group on days 1, 2, and 3 of treatment (P \u003c .05). Mechanical ventilation at age 1 week was required in 27 of 64 infants in the fentanyl group (42.2%), compared with 17 of 67 infants in the placebo group (25.4%) (P = .042). The first cycle of mechanical ventilation was longer and the first meconium passage occurred later in the fentanyl group (P = .019 and .027, respectively).\nCONCLUSION: In very preterm infants on mechanical ventilation, continuous fentanyl infusion plus open-label boluses of fentanyl does not reduce prolonged pain, but does reduce acute pain and increase side effects compared with open-label boluses of fentanyl alone."}

{"project":"yangbin123xm_800_3","denotations":[{"id":"T1","span":{"begin":46,"end":54},"obj":"CI"},{"id":"T2","span":{"begin":209,"end":217},"obj":"CI"},{"id":"T3","span":{"begin":235,"end":243},"obj":"CI"},{"id":"T4","span":{"begin":461,"end":469},"obj":"CI"},{"id":"T5","span":{"begin":494,"end":502},"obj":"CI"},{"id":"T6","span":{"begin":530,"end":538},"obj":"CI"},{"id":"T7","span":{"begin":610,"end":618},"obj":"CI"},{"id":"T8","span":{"begin":863,"end":871},"obj":"CI"},{"id":"T9","span":{"begin":958,"end":966},"obj":"CI"},{"id":"T10","span":{"begin":1096,"end":1104},"obj":"CI"},{"id":"T11","span":{"begin":1292,"end":1300},"obj":"CI"},{"id":"T12","span":{"begin":1428,"end":1436},"obj":"CI"},{"id":"T13","span":{"begin":1630,"end":1638},"obj":"CI"},{"id":"T14","span":{"begin":1754,"end":1762},"obj":"CI"},{"id":"T15","span":{"begin":1799,"end":1807},"obj":"CI"},{"id":"T16","span":{"begin":1929,"end":1937},"obj":"CI"},{"id":"T17","span":{"begin":75,"end":91},"obj":"DP"},{"id":"T18","span":{"begin":543,"end":550},"obj":"CI"},{"id":"T19","span":{"begin":575,"end":582},"obj":"CI"},{"id":"T20","span":{"begin":908,"end":915},"obj":"CI"},{"id":"T21","span":{"begin":1140,"end":1147},"obj":"CI"},{"id":"T22","span":{"begin":1260,"end":1267},"obj":"CI"},{"id":"T23","span":{"begin":1490,"end":1497},"obj":"CI"},{"id":"T24","span":{"begin":1700,"end":1715},"obj":"DP"},{"id":"T25","span":{"begin":255,"end":270},"obj":"DP"}],"text":"Efficacy and safety of continuous infusion of fentanyl for pain control in preterm newborns on mechanical ventilation.\nOBJECTIVE: To evaluate the analgesic superiority and the safety equivalence of continuous fentanyl infusions versus fentanyl boluses in preterm infants on mechanical ventilation.\nSTUDY DESIGN: In this multicenter, double-blind, randomized controlled trial, mechanically ventilated newborns (≤ 32(+6) weeks gestational age) were randomized to fentanyl (continuous infusion of fentanyl plus open-label boluses of fentanyl) or placebo (continuous infusion of placebo plus open-label boluses of fentanyl). The primary endpoint was analgesic efficacy, as evaluated by the Echelle Douleur Inconfort Nouveau-Né (EDIN) and Premature Infant Pain Profile scales. Safety variables were evaluated as well.\nRESULTS: Sixty-four infants were allocated to the fentanyl group, and 67 were allocated to the placebo group. The need for open-label boluses of fentanyl was similar in the 2 groups (P = .949). EDIN scores were comparable in the 2 groups; 65 of 961 (6.8%) EDIN scores were \u003e6 in the fentanyl group and 91 of 857 (10.6%) in the placebo group (P = .003). The median Premature Infant Pain Profile score was clinically and statistically higher in the placebo group compared with the fentanyl group on days 1, 2, and 3 of treatment (P \u003c .05). Mechanical ventilation at age 1 week was required in 27 of 64 infants in the fentanyl group (42.2%), compared with 17 of 67 infants in the placebo group (25.4%) (P = .042). The first cycle of mechanical ventilation was longer and the first meconium passage occurred later in the fentanyl group (P = .019 and .027, respectively).\nCONCLUSION: In very preterm infants on mechanical ventilation, continuous fentanyl infusion plus open-label boluses of fentanyl does not reduce prolonged pain, but does reduce acute pain and increase side effects compared with open-label boluses of fentanyl alone."}