title: 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.
authors.affiliation: Département Anesthésie-Réanimation, CHU 49036, Angers, France.
authors.forename: J C
authors.initials: JC
authors.lastname: Granry
authors.forename: B
authors.initials: B
authors.lastname: Rod
authors.forename: J P
authors.initials: JP
authors.lastname: Monrigal
authors.forename: J
authors.initials: J
authors.lastname: Merckx
authors.forename: J
authors.initials: J
authors.lastname: Berniere
authors.forename: N
authors.initials: N
authors.lastname: Jean
authors.forename: E
authors.initials: E
authors.lastname: Boccard
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000293:Adolescent; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001133:Bones of Upper Extremity / Q000601:surgery*; D002648:Child; D004311:Double-Blind Method; D005076:Exanthema / Q000139:chemically induced; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D007867:Leg Bones / Q000601:surgery*; D008297:Male; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D010919:Placebos; D011355:Prodrugs / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012449:Safety; D014839:Vomiting / Q000139:chemically induced
chemical_list: D018712:Analgesics, Non-Narcotic; D010919:Placebos; D011355:Prodrugs; D000082:Acetaminophen; C063776:propacetamol