• Paediatric anaesthesia · Jan 1997

    Randomized Controlled Trial Comparative Study Clinical Trial

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

    • J C Granry, B Rod, J P Monrigal, J Merckx, J Berniere, N Jean, and E Boccard.
    • Département Anesthésie-Réanimation, CHU 49036, Angers, France.
    • Paediatr Anaesth. 1997 Jan 1;7(6):445-9.

    AbstractThe 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.

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