Oral compared with intravenous sedation for first-trimester surgical abortion: a randomized controlled trial.
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.
Allen
Rebecca H
RH
Departments of 1Obstetrics and Gynecology, Women and Infants' Hospital, Providence, Rhode Island, USA. rhallen@wihri.org
Fitzmaurice
Garrett
G
Lifford
Karen L
KL
Lasic
Morana
M
Goldberg
Alisa B
AB
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
D018686:Anesthetics, Intravenous; D006993:Hypnotics and Sedatives