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Table 2 Randomized controlled trials comparing the effectiveness of oral paracetamol to oral ibuprofen in closing patent ductus arteriosus (PDA)

From: Efficacy and safety of intravenous paracetamol in comparison to ibuprofen for the treatment of patent ductus arteriosus in preterm infants: study protocol for a randomized control trial

Author Year

Number of patients

GA (weeks)

Mean postnatal age

Treatment dosage

Results

Dang 2013 [23]

160

≤ 34

≤ 14 days

Paracetamol: 15 mg/kg every 6 h for 3 days

Overall, PDA closure occurred in 65 patients (81.2 %) in the paracetamol group and in 63 patients (78.8 %) in the ibuprofen group (P = 0.693).

Ibuprofen: 10 mg/kg followed by 5 mg/kg after 24 and 48 h

The rate of gastrointestinal bleeding and hyperbilirubinemia was significantly higher in the ibuprofen group with respect to the paracetamol group (P < 0.05). No significant differences were found for other major adverse events.

Oncel 2014 [24]

90

≤ 30

48–96 h

Paracetamol: 15 mg/kg every 6 h for 3 days

After the first treatment course, the PDA closed in 29 (72.5 %) patients enrolled in the paracetamol group versus 31 (77.5 %) patients assigned to the ibuprofen group (P = 0.6). The cumulative closure rates after the second treatment course were high in both groups: only 1 patient (2.5 %) in the paracetamol group and 2 patients (5 %) in the ibuprofen group required surgical ligation.

Ibuprofen: 10 mg/kg followed by 5 mg/kg after 24 and 48 h

Bilirubin and liver enzyme levels before and after each treatment course were not significantly different between groups. No patient showed oliguria.