The analgesic efficacy of an injectable prodrug of acetaminophen in children after orthopaedic surgery

Abstract

The analgesic efficacy and safety of propacetamol, an injectable prodrug of acetaminophen, (paracetamol) were studied in 87 children (36 boys, 51 girls; age 6-13; mean age 9.5 years) immediately after limb surgery. Using a double-blind, randomized, parallel group design, the effects of a single IV infusion of 30 mg.kg-1 propacetamol (i.e. 15 mg.kg-1 acetaminophen) were compared with a single injection of placebo (PL). Efficacy was assessed on pain scores rated on a four-point verbal scale, a five-point visual scale (faces) and on a four-point relief verbal scale before administration (T0) and 0.25, 0.5, 1, 2, 3, 4, 5, 6 h after administration. At the end the global efficacy was rated by the physician on a five-point verbal scale. Propacetamol was statistically superior to placebo on all assessment criteria. Seven side-effects were recorded: five in the propacetamol group and two in the placebo group. 30 mg.kg-1 propacetamol provided a significantly greater analgesic effect than placebo in children after orthopaedic surgery.