The efficacy of intravenous paracetamol versus dipyrone for postoperative analgesia after day-case lower abdominal surgery in children with spinal anesthesia: a prospective randomized double-blind placebo-controlled study

Abstract

Background: A multimodal and preventative approach to providing postoperative analgesia is becoming increasingly popular for children and adults, with the aim of reducing reliance on opioids. We conducted a prospective, randomized double-blind study to compare the analgesic efficacy of intravenous paracetamol and dipyrone in the early postoperative period in school-age children undergoing lower abdominal surgery with spinal anesthesia.

Methods: Sixty children scheduled for elective lower abdominal surgery under spinal anesthesia were randomized to receive either intravenous paracetamol 15 mg/kg, dipyrone 15 mg/kg or isotonic saline. The primary outcome measure was pain at rest, assessed by means of a visual analog scale 15 min, 30 min, 1 h, 2 h, 4 h and 6 h after surgery. If needed, pethidine 0.25 mg/kg was used as the rescue analgesic. Time to first administration of rescue analgesic, cumulative pethidine requirements, adverse effects and complications were also recorded.

Results: There were no significant differences in age, sex, weight, height or duration of surgery between the groups. Pain scores were significantly lower in the paracetamol group at 1 h (P = 0.030) and dipyrone group at 2 h (P = 0.010) when compared with placebo. The proportion of patients requiring rescue analgesia was significantly lower in the paracetamol and dipyrone groups than the placebo group (vs. paracetamol P = 0.037; vs. dipyrone P = 0.020). Time to first analgesic requirement appeared shorter in the placebo group but this difference was not statistically significant, nor were there significant differences in pethidine requirements, adverse effects or complications.

Conclusion: After lower abdominal surgery conducted under spinal anesthesia in children, intravenous paracetamol appears to have similar analgesic properties to intravenous dipyrone, suggesting that it can be used as an alternative in the early postoperative period.

Trial registration: Clinical Trials.gov. Identifier: NCT01858402.

Figures

Figure 1

Flow chart of the study design.

Figure 2

Visual analog pain scores in the first 6 h after surgery. Values shown are mean ± standard deviation. *P = 0.030 paracetamol versus placebo, #P = 0.010 dipyrone versus placebo.

Figure 3

Rescue analgesic requirements in the first 6 h after surgery. Values are shown are number and proportion. h: postoperative hours. *P = 0.037 paracetamol versus placebo, *P = 0.020 dipyrone versus placebo.