Trial Outcomes & Findings for Oral Ketorolac for Pain Relief During IUD Insertion (NCT NCT03031795)
NCT ID: NCT03031795
Last Updated: 2018-09-26
Results Overview
Pain before, during and after IUD placement on a 0 (no pain) to 10 (worst possible) scale. Higher score mean a worse outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
71 participants
Primary outcome timeframe
Before, during and after IUD placement
Results posted on
2018-09-26
Participant Flow
Participant milestones
| Measure |
Experimental
ketorolac, oral, 20 mg, 1 dose, 45 minutes prior to IUD placement
Ketorolac: Oral Tablet
|
Placebo
look alike placebo
Placebos
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
36
|
|
Overall Study
COMPLETED
|
35
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oral Ketorolac for Pain Relief During IUD Insertion
Baseline characteristics by cohort
| Measure |
Ketorolac
n=35 Participants
Experimental group
|
Placebo
n=36 Participants
Control group
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.9 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
30.7 years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
31.3 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · White
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Black
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Other
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/ethnicity · Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Before, during and after IUD placementPain before, during and after IUD placement on a 0 (no pain) to 10 (worst possible) scale. Higher score mean a worse outcome.
Outcome measures
| Measure |
Ketorolac
n=35 Participants
Experimental group
|
Placebo
n=36 Participants
Placebo group
|
|---|---|---|
|
Pain Before, During and After IUD Placement
Pain expected during the procedure
|
4.1 units on a scale
Standard Deviation 2.2
|
4.5 units on a scale
Standard Deviation 2.4
|
|
Pain Before, During and After IUD Placement
Pre-procedure pain rating
|
0.4 units on a scale
Standard Deviation 1.0
|
0.7 units on a scale
Standard Deviation 1.5
|
|
Pain Before, During and After IUD Placement
Tenaculum placement
|
2.7 units on a scale
Standard Deviation 2.2
|
3.2 units on a scale
Standard Deviation 2.4
|
|
Pain Before, During and After IUD Placement
Uterine sounding
|
3.3 units on a scale
Standard Deviation 2.9
|
4.2 units on a scale
Standard Deviation 2.9
|
|
Pain Before, During and After IUD Placement
Deployment of the IUD
|
4.2 units on a scale
Standard Deviation 2.9
|
5.7 units on a scale
Standard Deviation 2.9
|
|
Pain Before, During and After IUD Placement
Overall pain rating during the procedure
|
3.6 units on a scale
Standard Deviation 2.9
|
4.9 units on a scale
Standard Deviation 2.7
|
|
Pain Before, During and After IUD Placement
Level of pain 10 minutes post procedure
|
1.1 units on a scale
Standard Deviation 1.5
|
2.5 units on a scale
Standard Deviation 2.5
|
Adverse Events
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
John O. Elliott PhD, MPH Research Specialist Medical Education
OhioHealth
Phone: 614-566-3643
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place