Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage

Not Applicable

Completed

Brief Summary: The aim of this study is to compare the effect of pre-procedural ketorolac to ibuprofen on immediate post-procedural pain scores in patients undergoing first trimester suction curettage with local anesthesia only.

Our primary hypothesis is that IM ketorolac compared to oral ibuprofen will result in an approximate 30% reduction in pain scores on a 21-point numerical rating scale immediately after the procedure.

Secondary hypotheses include:

* Pain scores on the 21-point scale will also be significantly lower in the ketorolac group immediately after cervical dilation and 15 minutes post-procedure.

* Fewer patients in the ketorolac group will rate their pain as "severe" on a subjective pain rating scale.

* Patients in the ketorolac group will be more satisfied with their pain control.

* Side effects will be similar between groups.

Recruitment & Eligibility

Inclusion Criteria

Women age 18 or older seeking suction curettage at Planned Parenthood League of Massachusetts (PPLM)
Gestational age less than or equal to 11+6, confirmed by ultrasound
Eligible for suction curettage according to PPLM protocols
Choice of local anesthesia

Exclusion Criteria

Active renal disease Active hepatic disease Gastric ulcer disease or gastritis Long-term NSAID or aspirin use Bleeding disorder

NSAIDs taken < 8 hours prior to procedure
Need for cervical ripening with either misoprostol or mechanical priming agent (laminaria/Dilapan)
Long-term narcotic use
Unable or unwilling to complete required study procedures
Previous participation in the study

Arm && Interventions

Group	Intervention	Description
Ketorolac	Ketorolac	Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)
Ibuprofen	Ibuprofen	Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo

Primary Outcome Measures

Name	Time	Method
Immediate Post-procedure Pain Score	Immediately (within 1 minute) after suction and speculum removal	The primary endpoint is subjects' immediate post-procedure pain score on a 21-point 0 to 100 scale, 0 = no pain and 100 = worst possible pain (in increments of five). This scale has been previously validated and used for research purposes, including for pain research evaluating suction curettage elsewhere and at our institution (Jensen 1986, Williamson 2004, Allen 2009).

Secondary Outcome Measures

Name	Time	Method
Pain Scores 15 Minutes Post-procedure	Fifteen minutes after the procedure	21-point 0 to 100 scale, where 0 = no pain and 100 = worst possible pain (in increments of five)
Pain Scores Immediately After Cervical Dilation	Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula	21-point 0 to 100 scale where 0 = no pain and 100 = worst possible pain (in increments of five)