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

NCT01595282 — Not applicable, Completed, 94 participants, Planned Parenthood League of Massachusetts

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Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage: a Randomized Clinical Trial.

Registry	NCT01595282
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	94 (Actual)
Sponsor	Planned Parenthood League of Massachusetts (Other); collaborators: Society of Family Planning
Conditions	Pain
Interventions	Ketorolac, Ibuprofen (Drug)
Dates	start 2011-06-01, primary completion 2012-06-01, completion 2012-06-01, first posted 2012-05-10, last updated 2014-07-02
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Ketorolac	Experimental	Drug: 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	Active comparator	Drug: 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

Ketorolac (Drug), also known as Toradol: 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
Ibuprofen (Drug): For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure.

+Outcome measures

Primary outcomes

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 outcomes

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)
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)

+Eligibility

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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

+Posted results

Participant flow

Milestone	Ketorolac	Ibuprofen
Started	47	47
Completed	47	47
Not completed	0	0

Outcome results

Immediate Post-procedure Pain Score (Primary), Mean, units on a scale: Ketorolac 52.3 +/- 29.1; Ibuprofen 56.2 +/- 30.2
Pain Scores Immediately After Cervical Dilation (Secondary), Mean, units on a scale: Ketorolac 41.6 +/- 27.72; Ibuprofen 45.4 +/- 28.54
Pain Scores 15 Minutes Post-procedure (Secondary), Mean, units on a scale: Ketorolac 22.3 +/- 20.8; Ibuprofen 15.0 +/- 17.3

Adverse events

Arm	Deaths	Serious adverse events	Other adverse events
Ketorolac	0	0/47 (0.0%)	0/47 (0.0%)
Ibuprofen	0	0/47 (0.0%)	0/47 (0.0%)

+Locations (1)

Facility	City	Country	Status
Planned Parenthood League of Massachusetts	Boston, Massachusetts	United States

+Investigators

Principal Investigator, MD, MPH, Principal investigator, Planned Parenthood League of Massachusetts

My Notes

Public

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