There is a substantial research gap regarding analgesic interventions for children and adolescents with chronic pain. Most clinical trials in the field focus on the evaluation of non-pharmacological interventions and are of low methodological quality. There is also a specific lack of trials involving infants and children and adolescents with long-lasting diseases.

BackgroundPatent ductus arteriosus (PDA) is common in very premature infants. Pharmacological closure of PDA with indomethacin, a prostaglandin inhibitor, has remained the mainstay of treatment in premature infants over the last three decades. Intravenous ibuprofen was recently shown to be as effective and to have fewer adverse reaction in preterm infants. If equally effective, then oral ibuprofen for PDA closure would have several important advantages over the intravenous route.This study was designed to assess the efficacy and safety of oral ibuprofen and intravenous ibuprofen for the early pharmacological treatment of PDA in LBW preterm infants with respiratory distress syndrome. MethodsA randomized, singleblinded, controlled study was performed on premature neonates at the neonatal care unit of the University Hospital for Obstetrics and GynecologyKoco Gliozheni, Tirana, Albania, from January 2010 to December 2012. The study enrolled 68 preterm infants with gestational age between 2832 weeks, birth weight ≤ 2000 g, postnatal age 4896 h, and had echocardiographically confirmed significant PDA. The preterm infants received either intravenous or oral ibuprofen randomly as an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h. After the first dose of treatment in both groups, echocardiographic evaluation was performed, to determine the need for a second or third dose. The rate of ductal closure, adverse effects, complications, and the patients clinical course were recorded. ResultsAll patients were born after 28 until 32 weeks gestation. 36 patients were treated with oral ibuprofen and 32 with intravenous ibuprofen in this period. After the first course of the treatment, the PDA closed in 30 (83.3%) of the patients assigned to the oral ibuprofen group versus 23 (71.8%) of those enrolled in the intravenous ibuprofen group (p = 0.355). There was no difference between treatment groups in demographics or baseline renal function. In the evaluation of renal tolerance, none of the patients had oliguria. There were no significant differences with respect to complications during the stay. ConclusionsIn low birth weight infants, the rate of early ductal closure with oral ibuprofen is at least as good as with the intravenous route. Oral ibuprofen is associated with fewer adverse effects.■ UDC: 100 110 ■ Patent ductus arteriosus ■ Ibuprofen ■ LBW infants ■ Adverse effects ■

Objective -This study was to assess the efficacy and safety of oral ibuprofen and intravenous ibuprofen for the early pharmacological treatment of patent ductus arteriosus (PDA) in preterm infants. Methods -A randomized, single-blinded, controlled study was performed on premature neonates at the neonatal unit tertiary care hospital, from January 2010 to December 2012. The study enrolled 80 preterm infants with gestational age between 28-32 weeks, birth weight ≤ 2000 g, postnatal age 48-96 h, and with echocardiographically confirmed significant PDA (a duct size >1.5 mm). The preterm infants received either intravenous or oral ibuprofen randomly as an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h after the first dose (the first treatment course). Serum creatinine (sCr), blood urea nitrogen (BUN) and urine output (UO) were recorded prior to treatment, before each dose and after the first treatment course. Results -Forty patients were treated with oral ibuprofen and 40 with intravenous ibuprofen in this period. There was no difference between treatment groups in demographics or baseline renal function. After the first course of the treatment, the PDA closed in 28 (70%) of the patients assigned to the oral ibuprofen group, versus 23 (57.5%) of those enrolled in the intravenous ibuprofen group (p=0.35). In the evaluation of renal tolerance, none of the patients had oliguria. Moreover, in patients who underwent a second course of intravenous therapy, the urinary output significantly decreased, but the sCr levels after the first and after the second treatment course did not differ significantly from the baseline for each group. 7.5% of the intravenous group underwent surgery, versus 0% of the oral group. (p=0.23) Conclusions -Successful pharmacological closure of PDA can be achieved by the use of ibuprofen orally or intravenously, without statistically significant difference in efficacy and safety between the two treatments. Patients treated with ibuprofen intravenously probably have a much higher risk of undergoing surgery.

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