title: Remifentanil versus placebo for analgesia during external cephalic version: a randomised clinical trial.
abstract: BACKGROUND
  Breech presentation occurs in up to 3% of pregnancies at term and may be an indication for caesarean delivery. External cephalic version can be effective in repositioning the fetus in a cephalic presentation, but may be painful for the mother. Our aim was to assess the efficacy of remifentanil versus placebo for pain relief during external cephalic version.
  
  
  METHODS
  A randomized, double-blind, controlled trial that included women at 36-41 weeks of gestation with non-cephalic presentations was performed. Women were randomized to receive either a remifentanil infusion at 0.1 μg/kg/min and demand boluses of 0.1 μg/kg, or saline placebo. The primary outcome was the numerical rating pain score (0-10) after external cephalic version.
  
  
  RESULTS
  Sixty women were recruited, 29 in the control group and 31 in the remifentanil group. There were significant differences in pain scores at the end of the procedure (control 6.5 ± 2.4 vs. remifentanil 4.7 ± 2.5, P = 0.005) but not 10 min later (P = 0.054). The overall success rate for external cephalic version was 49% with no significant differences between groups (remifentanil group 54.8% vs. control group 41.3%, P = 0.358). In the remifentanil group, there was one case of nausea and vomiting, one of drowsiness and three cases of fetal bradycardia. In the control group, there were three cases of nausea and vomiting, one of dizziness and nine cases of fetal bradycardia.
  
  
  CONCLUSIONS
  Intravenous remifentanil with bolus doses on demand during external cephalic version achieved a reduction in pain and increased maternal satisfaction. There were no additional adverse effects, and no difference in the success rate of external cephalic version or the incidence of fetal bradycardia.
authors.affiliation: Department of Anaesthesiology and Resuscitation, Araba University Hospital, Vitoria-Gasteiz, Spain.
authors.forename: H
authors.initials: H
authors.lastname: Muñoz
authors.affiliation: Department of Gynecology and Obstetrics, Araba University Hospital, Vitoria-Gasteiz, Spain.
authors.forename: S
authors.initials: S
authors.lastname: Guerra
authors.affiliation: Department of Anaesthesiology and Resuscitation, Araba University Hospital, Vitoria-Gasteiz, Spain.
authors.forename: P
authors.initials: P
authors.lastname: Perez-Vaquero
authors.affiliation: Department of Anaesthesiology and Resuscitation, Araba University Hospital, Vitoria-Gasteiz, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Valero Martinez
authors.affiliation: Research Unit, Araba University Hospital, Vitoria-Gasteiz, Spain.
authors.forename: F
authors.initials: F
authors.lastname: Aizpuru
authors.affiliation: Research Unit, Araba University Hospital, Vitoria-Gasteiz, Spain. Electronic address: Amanda.lopezpicado@osakidetza.net.
authors.forename: A
authors.initials: A
authors.lastname: Lopez-Picado
mesh_terms: D000328:Adult; D000698:Analgesia / Q000379:methods*; D000701:Analgesics, Opioid / Q000009:adverse effects / Q000627:therapeutic use*; D001919:Bradycardia / Q000139:chemically induced; D001946:Breech Presentation / Q000628:therapy; D004244:Dizziness / Q000139:chemically induced; D004311:Double-Blind Method; D005260:Female; D005315:Fetal Diseases / Q000139:chemically induced; D006801:Humans; D009325:Nausea / Q000139:chemically induced; D010146:Pain / Q000188:drug therapy* / Q000209:etiology*; D059408:Pain Management / Q000379:methods; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D010880:Piperidines / Q000009:adverse effects / Q000627:therapeutic use*; D010919:Placebos; D011247:Pregnancy; D000077208:Remifentanil; D016896:Treatment Outcome; D014710:Version, Fetal / Q000009:adverse effects* / Q000379:methods; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000701:Analgesics, Opioid; D010880:Piperidines; D010919:Placebos; D000077208:Remifentanil
keywords: Analgesia; External cephalic version; Remifentanil