N/A
N=94
Intramuscular Ketorolac Versus Oral Ibuprofen for Pain Relief in First Trimester Suction Curettage
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01595282 ↗Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Immediate Post-procedure Pain Score — 52.3; 56.2 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Ketorolac (Drug); Ibuprofen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Planned Parenthood League of Massachusetts
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immediate Post-procedure Pain Score |
52.3; 56.2 | — |
| SECONDARY Pain Scores Immediately After Cervical Dilation |
41.6; 45.4 | — |
| SECONDARY Pain Scores 15 Minutes Post-procedure |
22.3; 15.0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01595282). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.