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

Planned Parenthood League of Massachusetts94 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Pain

Interventions

For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: * Choice of IV sedation for pain control * Hypersensitivity to NSAIDs or lidocaine * Contraindications to NSAIDs: 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

Outcomes

Primary Outcomes

Immediate Post-procedure Pain Score

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).

Time frame: Immediately (within 1 minute) after suction and speculum removal

Secondary Outcomes

Pain Scores Immediately After Cervical Dilation

21-point 0 to 100 scale where 0 = no pain and 100 = worst possible pain (in increments of five)

Time frame: Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula

Pain Scores 15 Minutes Post-procedure

21-point 0 to 100 scale, where 0 = no pain and 100 = worst possible pain (in increments of five)

Time frame: Fifteen minutes after the procedure