title: Patient-controlled oral analgesia versus nurse-controlled parenteral analgesia after caesarean section: a randomised controlled trial.
abstract: We assessed the effectiveness of early patient-controlled oral analgesia compared with parenteral analgesia in a randomised controlled non-inferiority trial of women undergoing elective caesarean section under regional anaesthesia. Seventy-seven women received multimodal paracetamol, ketoprofen and morphine analgesia. The woman having patient-controlled oral analgesia were administered four pillboxes on the postnatal ward containing tablets and instructions for self-medication, the first at 7 h after the spinal injection and then three more at 12-hourly intervals. Pain at rest and on movement was evaluated using an 11-point verbal rating scale at 2 h and then at 6-hourly intervals for 48 h. The pre-defined non-inferiority limit for the difference in mean pain scores (patient-controlled oral analgesia minus parenteral) was one. The one-sided 95% CI of the difference in mean pain scores was significantly lower than one at all time-points at rest and on movement, demonstrating non-inferiority of patient-controlled oral analgesia. More women used morphine in the patient-controlled oral analgesia group (22 (58%)) than in the parenteral group (9 (23%); p = 0.002). The median (IQR [range]) number of morphine doses in the patient-controlled oral analgesia group was 2 (1-3 [1-7]) compared with 1 (1-1 [1-2]); p = 0.006) in the parenteral group. Minor drug errors or omissions were identified in five (13%) women receiving patient-controlled oral analgesia. Pruritus was more frequent in the patient-controlled oral analgesia group (14 (37%) vs 6 (15%) respectively; p = 0.03), but no differences were noted for other adverse events and maternal satisfaction. After elective caesarean section, early patient-controlled oral analgesia is non-inferior to standard parenteral analgesia for pain management, and can be one of the steps of an enhanced recovery process.
authors.affiliation: Department of Anaesthesiology, Arnaud de Villeneuve University Hospital, Montpellier, France.
authors.forename: A
authors.initials: A
authors.lastname: Bonnal
authors.affiliation: Department of Anaesthesiology, Arnaud de Villeneuve University Hospital, Montpellier, France.
authors.forename: A
authors.initials: A
authors.lastname: Dehon
authors.affiliation: Clinical Research and Epidemiology Unit, Medical Information Department, Montpellier University Hospital, Montpellier, France.
authors.forename: N
authors.initials: N
authors.lastname: Nagot
authors.affiliation: Clinical Research and Epidemiology Unit, Medical Information Department, Montpellier University Hospital, Montpellier, France.
authors.forename: V
authors.initials: V
authors.lastname: Macioce
authors.affiliation: Clinical Research and Epidemiology Unit, Medical Information Department, Montpellier University Hospital, Montpellier, France.
authors.forename: E
authors.initials: E
authors.lastname: Nogue
authors.affiliation: Department of Anaesthesiology, Arnaud de Villeneuve University Hospital, Montpellier, France.
authors.forename: E
authors.initials: E
authors.lastname: Morau
mesh_terms: D000284:Administration, Oral; D000328:Adult; D016058:Analgesia, Patient-Controlled / Q000009:adverse effects / Q000379:methods*; D000701:Analgesics, Opioid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002585:Cesarean Section / Q000379:methods*; D023381:Endpoint Determination; D005260:Female; D006801:Humans; D007263:Infusions, Parenteral; D009020:Morphine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009726:Nurses; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D011247:Pregnancy; D011446:Prospective Studies; D011537:Pruritus / Q000139:chemically induced / Q000453:epidemiology
chemical_list: D000701:Analgesics, Opioid; D009020:Morphine
keywords: cesarean section; pain management; patient controlled analgesia; post operative pain; rehabilitation