title: Oral compared with intravenous sedation for first-trimester surgical abortion: a randomized controlled trial.
abstract: OBJECTIVE
  To test the equivalency of oral sedation and intravenous sedation for pain control in first-trimester surgical abortion.
  
  
  METHODS
  Women undergoing suction curettage at less than 13 weeks of gestation were randomly assigned to oral sedation, 10 mg of oxycodone and 1 mg of lorazepam, or intravenous sedation, 100 micrograms fentanyl and 2 mg midazolam. All patients received 800 mg of preoperative ibuprofen and a 20-mL paracervical block with 1% lidocaine. The primary outcome was intraoperative pain as measured on a 21-point verbal rating scale that had a range from 0 to 100 (0=no pain and 100=worst pain ever) with an equivalence margin for the treatment group comparison of +/-10.
  
  
  RESULTS
  Of 130 women, 65 were randomly assigned to oral sedation and 65 to intravenous sedation. The groups differed at baseline by age and preoperative ratings of depression, stress, and anxiety; however, when adjusted for these differences, the primary results were unaffected. Mean intraoperative pain scores, controlling for age and preoperative depression, stress, and anxiety, were 61.2 for oral sedation and 36.3 for intravenous sedation (mean difference 24.9, 95% confidence interval 15.9-33.9). Other findings included no difference in postoperative adverse effects and less satisfaction with pain control with oral sedation compared with intravenous sedation.
  
  
  CONCLUSIONS
  Oral sedation, as studied, is not equivalent to intravenous sedation for pain control during first-trimester surgical abortion.
  
  
  BACKGROUND
  : ClinicalTrials.gov, www.clinicaltrials.gov, NCT00337792
  
  
  METHODS
  I.
authors.affiliation: Departments of 1Obstetrics and Gynecology, Women and Infants' Hospital, Providence, Rhode Island, USA. rhallen@wihri.org
authors.forename: Rebecca H
authors.initials: RH
authors.lastname: Allen
authors.forename: Garrett
authors.initials: G
authors.lastname: Fitzmaurice
authors.forename: Karen L
authors.initials: KL
authors.lastname: Lifford
authors.forename: Morana
authors.initials: M
authors.lastname: Lasic
authors.forename: Alisa B
authors.initials: AB
authors.lastname: Goldberg
mesh_terms: D000028:Abortion, Induced; D000284:Administration, Oral; D000328:Adult; D018686:Anesthetics, Intravenous / Q000627:therapeutic use*; D016292:Procedural Sedation / Q000379:methods*; D005260:Female; D006801:Humans; D006993:Hypnotics and Sedatives / Q000008:administration & dosage*; D010146:Pain / Q000517:prevention & control*; D010147:Pain Measurement; D017060:Patient Satisfaction; D011247:Pregnancy; D055815:Young Adult
chemical_list: D018686:Anesthetics, Intravenous; D006993:Hypnotics and Sedatives