Pain
Conditions
Keywords
pain, suction curettage
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.
Interventions
DRUGKetorolac
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
DRUGIbuprofen
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.
Sponsors
Society of Family Planning
Planned Parenthood League of Massachusetts
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Recruitment details
Dates of recruitment period: June 2011-May 2012 Clinic: free-standing, outpatient health center
Participants by arm
| Arm | Count |
|---|---|
| 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)
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 | 47 |
| 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
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. | 47 |
| Total | 94 |
Baseline characteristics
| Characteristic | Total | Ketorolac | Ibuprofen |
|---|---|---|---|
| Age, Continuous | 25.9 years STANDARD_DEVIATION 5.6 | 26.4 years STANDARD_DEVIATION 6.4 | 25.3 years STANDARD_DEVIATION 4.7 |
| Race/Ethnicity, Customized African American/Black | 37 participants | 20 participants | 17 participants |
| Race/Ethnicity, Customized Asian | 7 participants | 3 participants | 4 participants |
| Race/Ethnicity, Customized Multiracial | 5 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized Other | 20 participants | 11 participants | 9 participants |
| Race/Ethnicity, Customized White | 25 participants | 11 participants | 14 participants |
| Region of Enrollment United States | 94 participants | 47 participants | 47 participants |
| Sex: Female, Male Female | 94 Participants | 47 Participants | 47 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 47 | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 | 0 / 47 |
Outcome results
Primary
Immediate Post-procedure Pain Score
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).
Time frame: Immediately (within 1 minute) after suction and speculum removal
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Immediate Post-procedure Pain Score | 52.3 units on a scale | Standard Deviation 29.1 |
| Ibuprofen | Immediate Post-procedure Pain Score | 56.2 units on a scale | Standard Deviation 30.2 |
Secondary
Pain Scores 15 Minutes Post-procedure
21-point 0 to 100 scale, where 0 = no pain and 100 = worst possible pain (in increments of five)
Time frame: Fifteen minutes after the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Pain Scores 15 Minutes Post-procedure | 22.3 units on a scale | Standard Deviation 20.8 |
| Ibuprofen | Pain Scores 15 Minutes Post-procedure | 15.0 units on a scale | Standard Deviation 17.3 |
Secondary
Pain Scores Immediately After Cervical Dilation
21-point 0 to 100 scale where 0 = no pain and 100 = worst possible pain (in increments of five)
Time frame: Immediately (within 1 minute) after cervical dilation prior to the introduction of the suction cannula
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ketorolac | Pain Scores Immediately After Cervical Dilation | 41.6 units on a scale | Standard Deviation 27.72 |
| Ibuprofen | Pain Scores Immediately After Cervical Dilation | 45.4 units on a scale | Standard Deviation 28.54 |