Prophylactic compared with therapeutic ibuprofen analgesia in first-trimester medical abortion: a randomized controlled trial.
OBJECTIVE
To compare the effectiveness of two oral analgesic regimens in first-trimester medical abortion.


METHODS
We randomly assigned 250 participants undergoing first-trimester abortion with mifepristone and misoprostol at three clinics to two ibuprofen regimens: therapeutic (800 mg every 4-6 hours as needed for pain) or prophylactic (800 mg starting 1 hour before the misoprostol dose, then every 4-6 hours for 48 hours regardless of pain, then as needed). We asked each participant to record her maximum pain on a scale of 0-10 daily thereafter.


RESULTS
Of participants assigned to the prophylactic and therapeutic regimens, 111 of 123 (90%) and 117 of 127 (92%), respectively, provided follow-up data. More than 80% of the participants in each group complied with their assigned treatment. Participants in the prophylactic group used substantially more ibuprofen than those in the therapeutic group (median of nine and four tablets, respectively). The mean maximum pain score was 7.1 in the prophylactic group and 7.3 in the therapeutic group (standard deviations 2.5 and 2.2, respectively); the difference was not statistically significant (P=.87, adjusted for site). Duration of pain, verbal pain ratings reported at follow-up, and use of other analgesics did not differ significantly by group (all P>.05). No significant benefit of the prophylactic regimen was apparent in any population subgroup. Abortion failure and ibuprofen side effects in the two groups were similar.


CONCLUSIONS
We found no evidence that prophylactic administration of ibuprofen reduces pain severity or duration in first-trimester medical abortion. The average pain severity experienced by participants using both regimens was high.


BACKGROUND
ClinicalTrials.gov, www.clinicaltrials.gov, NCT01457521.


METHODS
I.
Gynuity Health Projects and Planned Parenthood of New York City, New York, New York 10010, USA. eraymond@gynuity.org
Elizabeth G
EG
Raymond
Mark A
MA
Weaver
Karmen S
KS
Louie
Gillian
G
Dean
Lauren
L
Porsch
E Steve
ES
Lichtenberg
Rose
R
Ali
Michelle
M
Arnesen
D000021:Abortifacient Agents, Steroidal; D000028:Abortion, Induced; D000293:Adolescent; D000328:Adult; D000698:Analgesia / Q000379:methods*; D018712:Analgesics, Non-Narcotic / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage*; D015735:Mifepristone; D016595:Misoprostol; D011247:Pregnancy; D011261:Pregnancy Trimester, First; D055815:Young Adult
D000021:Abortifacient Agents, Steroidal; D018712:Analgesics, Non-Narcotic; D016595:Misoprostol; D015735:Mifepristone; D007052:Ibuprofen