title: The effects of a small-dose naloxone infusion on opioid-induced side effects and analgesia in children and adolescents treated with intravenous patient-controlled analgesia: a double-blind, prospective, randomized, controlled study.
abstract: Opioids are frequently associated with side effects such as nausea, vomiting, and pruritus. We hypothesized that a prophylactic, continuous small-dose naloxone infusion would reduce the incidence of opioid-induced side effects without affecting analgesia or opioid consumption. In this prospective, double-blind, randomized, controlled clinical trial, we studied 46 postoperative patients (M:F, 21:25), averaging 14 +/- 2.5 yr and 53 +/- 17 kg, at the start of morphine IV patient-controlled analgesia. Patients were randomized to either saline (control, n = 26) or naloxone 0.25 microg . kg(-1) . h(-1) (n = 20). We found that the incidence and severity of pruritus (77% versus 20%; P < 0.05) and nausea (70% versus 35%; P < 0.05) was significantly more frequent in the placebo group compared with the naloxone group. Morphine consumption (1.02 +/- 0.41 mg . kg(-1) . d(-1) versus 1.28 +/- 0.61 mg . kg(-1) . d(-1)), pain scores at rest (4 +/- 2 versus 3 +/- 2), and pain scores with coughing (6 +/- 2 versus 6 +/- 2) were not different. We conclude that, in children and adolescents, a small-dose naloxone infusion (0.25 microg . kg(-1) . h(-1)) can significantly reduce the incidence and severity of opioid-induced side effects without affecting opioid-induced analgesia. When initiating morphine IV patient-controlled analgesia for the treatment of moderate to severe pain, clinicians should strongly consider starting a concomitant small-dose naloxone infusion.
authors.affiliation: *Department of Anesthesiology, The Children's Hospital of Philadelphia, Pennsylvania; †Department of Anesthesiology, The Joe DiMaggio Children's Hospital, Hollywood, Florida; ‡Departments of Anesthesiology, Critical Care Medicine, and Pediatrics, The Johns Hopkins Medical Institutions; and §Department of Biostatistics, The Johns Hopkins University School of Public Health, Baltimore, Maryland.
authors.forename: Lynne G
authors.initials: LG
authors.lastname: Maxwell
authors.forename: Sandra C
authors.initials: SC
authors.lastname: Kaufmann
authors.forename: Sally
authors.initials: S
authors.lastname: Bitzer
authors.forename: Eric V
authors.initials: EV
authors.lastname: Jackson
authors.forename: John
authors.initials: J
authors.lastname: McGready
authors.forename: Sabine
authors.initials: S
authors.lastname: Kost-Byerly
authors.forename: Lori
authors.initials: L
authors.lastname: Kozlowski
authors.forename: Sharon K
authors.initials: SK
authors.lastname: Rothman
authors.forename: Myron
authors.initials: M
authors.lastname: Yaster
mesh_terms: D000293:Adolescent; D000328:Adult; D000698:Analgesia; D016058:Analgesia, Patient-Controlled; D000701:Analgesics, Opioid / Q000009:adverse effects* / Q000627:therapeutic use*; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D009270:Naloxone / Q000008:administration & dosage / Q000627:therapeutic use*; D009292:Narcotic Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D010147:Pain Measurement / Q000187:drug effects; D010149:Postoperative Pain / Q000150:complications / Q000188:drug therapy*; D020250:Postoperative Nausea and Vomiting / Q000188:drug therapy; D011446:Prospective Studies; D011537:Pruritus / Q000188:drug therapy / Q000523:psychology
chemical_list: D000701:Analgesics, Opioid; D009292:Narcotic Antagonists; D009270:Naloxone