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
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|
|Pain||Drug: Ketorolac Drug: Ibuprofen||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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)
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
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)
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|