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

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

Sponsors

Lead Sponsor: Planned Parenthood League of Massachusetts

Collaborator: Society of Family Planning

Source Planned Parenthood League of Massachusetts
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.

Overall Status Completed
Start Date June 2011
Completion Date June 2012
Primary Completion Date June 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Immediate Post-procedure Pain Score Immediately (within 1 minute) after suction and speculum removal
Secondary Outcome
Measure Time Frame
Pain Scores Immediately After Cervical Dilation Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula
Pain Scores 15 Minutes Post-procedure Fifteen minutes after the procedure
Enrollment 94
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ketorolac

Description: 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

Arm Group Label: Ketorolac

Other Name: Toradol

Intervention Type: Drug

Intervention Name: Ibuprofen

Description: 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.

Arm Group Label: Ibuprofen

Eligibility

Criteria:

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

Gender: Female

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Principal Investigator, MD, MPH Principal Investigator Planned Parenthood League of Massachusetts
Location
Facility: Planned Parenthood League of Massachusetts
Location Countries

United States

Verification Date

June 2014

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Ketorolac

Type: Experimental

Description: 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)

Label: Ibuprofen

Type: Active Comparator

Description: 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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov