Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage
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ClinicalTrials.gov Identifier: NCT01595282 |
Recruitment Status :
Completed
First Posted : May 10, 2012
Results First Posted : July 2, 2014
Last Update Posted : July 2, 2014
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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.
Condition or disease | Intervention/treatment | Phase |
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Pain | Drug: Ketorolac Drug: Ibuprofen | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 94 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage: a Randomized Clinical Trial. |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
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Experimental: 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)
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Drug: Ketorolac
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
Other Name: Toradol |
Active Comparator: 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
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Drug: Ibuprofen
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. |
- Immediate Post-procedure Pain Score [ Time Frame: 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).
- Pain Scores Immediately After Cervical Dilation [ Time Frame: 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 [ Time Frame: Fifteen minutes after the procedure ]21-point 0 to 100 scale, where 0 = no pain and 100 = worst possible pain (in increments of five)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01595282
United States, Massachusetts | |
Planned Parenthood League of Massachusetts | |
Boston, Massachusetts, United States, 02215 |
Principal Investigator: | Principal Investigator, MD, MPH | Planned Parenthood League of Massachusetts |
Responsible Party: | Planned Parenthood League of Massachusetts |
ClinicalTrials.gov Identifier: | NCT01595282 History of Changes |
Other Study ID Numbers: |
2011-p-000259 |
First Posted: | May 10, 2012 Key Record Dates |
Results First Posted: | July 2, 2014 |
Last Update Posted: | July 2, 2014 |
Last Verified: | June 2014 |
Keywords provided by Planned Parenthood League of Massachusetts:
pain suction curettage |
Additional relevant MeSH terms:
Ketorolac Ketorolac Tromethamine Ibuprofen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |