Trial Outcomes & Findings for Pain Control for Intrauterine Device Placement: A Trial of Ketorolac Prior to Intrauterine Device Placement (NCT NCT01664559)
NCT ID: NCT01664559
Last Updated: 2015-12-23
Results Overview
The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
Pain with IUD placement, measured immediately after placement
Results posted on
2015-12-23
Participant Flow
Participant milestones
| Measure |
Placebo With 1cc Normal Saline IM
If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection
|
Toradol, 30mg in 1cc IM
If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
|
Overall Study
COMPLETED
|
34
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pain Control for Intrauterine Device Placement: A Trial of Ketorolac Prior to Intrauterine Device Placement
Baseline characteristics by cohort
| Measure |
Placebo With 1cc Normal Saline IM
n=34 Participants
If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection
|
Toradol, 30mg in 1cc IM
n=33 Participants
If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.3 years
STANDARD_DEVIATION 5.4 • n=93 Participants
|
26.6 years
STANDARD_DEVIATION 5.1 • n=4 Participants
|
26.9 years
STANDARD_DEVIATION 5.3 • n=27 Participants
|
|
Sex/Gender, Customized
|
34 female participants
n=93 Participants
|
33 female participants
n=4 Participants
|
67 female participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
13 participants
n=93 Participants
|
12 participants
n=4 Participants
|
25 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
4 participants
n=93 Participants
|
2 participants
n=4 Participants
|
6 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
African American
|
14 participants
n=93 Participants
|
12 participants
n=4 Participants
|
26 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
1 participants
n=93 Participants
|
4 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=93 Participants
|
3 participants
n=4 Participants
|
5 participants
n=27 Participants
|
|
Body mass index
|
27.6 kg/m2
STANDARD_DEVIATION 5.7 • n=93 Participants
|
27.3 kg/m2
STANDARD_DEVIATION 5.8 • n=4 Participants
|
27.4 kg/m2
STANDARD_DEVIATION 5.7 • n=27 Participants
|
|
Gravidity
|
1 pregnancies
n=93 Participants
|
1 pregnancies
n=4 Participants
|
1 pregnancies
n=27 Participants
|
|
Parity
|
1 pregnancies
n=93 Participants
|
1 pregnancies
n=4 Participants
|
1 pregnancies
n=27 Participants
|
|
Currently breastfeeding
|
15 participants
n=93 Participants
|
15 participants
n=4 Participants
|
30 participants
n=27 Participants
|
|
History of loop electrosurgical excision procedure
|
0 participants
n=93 Participants
|
3 participants
n=4 Participants
|
3 participants
n=27 Participants
|
|
Level of education
Less than high school
|
0 participants
n=93 Participants
|
1 participants
n=4 Participants
|
1 participants
n=27 Participants
|
|
Level of education
High school graduate
|
7 participants
n=93 Participants
|
4 participants
n=4 Participants
|
11 participants
n=27 Participants
|
|
Level of education
Some college
|
12 participants
n=93 Participants
|
11 participants
n=4 Participants
|
23 participants
n=27 Participants
|
|
Level of education
College degree
|
7 participants
n=93 Participants
|
6 participants
n=4 Participants
|
13 participants
n=27 Participants
|
|
Level of education
Graduate degree
|
7 participants
n=93 Participants
|
11 participants
n=4 Participants
|
18 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Pain with IUD placement, measured immediately after placementThe patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever.
Outcome measures
| Measure |
Placebo With 1cc Normal Saline IM
n=34 Participants
If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection
|
Toradol, 30mg in 1cc IM
n=33 Participants
If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume
|
|---|---|---|
|
VAS (Visual Analogue Scale) Measurement of Pain
|
5.2 units on a scale
Interval 1.2 to 7.4
|
3.6 units on a scale
Interval 1.5 to 6.3
|
SECONDARY outcome
Timeframe: immediately after each step (see description)The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever. 1. Prior to injection of study drug, anticipated pain 2. Pain from study drug injection, measured immediately after injection 3. Pain from speculum insertion, measured immediately after insertion 4. Pain with tenaculum placement, measured immediately after placement 5. Pain with uterine sounding, measured immediately after removal of the sound 6. Pain at 5 minutes after placement of the intrauterine device 7. Pain at 15 minutes after placement of the intrauterine device
Outcome measures
| Measure |
Placebo With 1cc Normal Saline IM
n=34 Participants
If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection
|
Toradol, 30mg in 1cc IM
n=33 Participants
If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume
|
|---|---|---|
|
Pain Scores at Other Time Points During and After IUD Placement
Anticipated pain
|
4.4 cm
Interval 1.4 to 6.5
|
3.5 cm
Interval 1.0 to 6.8
|
|
Pain Scores at Other Time Points During and After IUD Placement
Pain with injection
|
1.0 cm
Interval 0.4 to 2.8
|
0.6 cm
Interval 0.2 to 1.3
|
|
Pain Scores at Other Time Points During and After IUD Placement
Speculum insertion
|
2.6 cm
Interval 0.6 to 3.7
|
1.5 cm
Interval 0.4 to 3.8
|
|
Pain Scores at Other Time Points During and After IUD Placement
Tenaculum placement
|
3.9 cm
Interval 2.6 to 5.7
|
2.5 cm
Interval 1.1 to 6.4
|
|
Pain Scores at Other Time Points During and After IUD Placement
Uterine sounding
|
5.0 cm
Interval 2.5 to 7.5
|
4.3 cm
Interval 1.7 to 7.2
|
|
Pain Scores at Other Time Points During and After IUD Placement
5 min after procedure
|
2.2 cm
Interval 0.8 to 3.9
|
0.3 cm
Interval 0.0 to 1.3
|
|
Pain Scores at Other Time Points During and After IUD Placement
15 min after procedure
|
1.6 cm
Interval 0.4 to 3.6
|
0.1 cm
Interval 0.0 to 0.9
|
SECONDARY outcome
Timeframe: immediately after each step (see description)The patient marked their pain on a 0 to 10cm visual analogue scale, where 0 cm is no pain and 10 cm is the worst pain ever. 1. Prior to injection of study drug, anticipated pain 2. Pain from study drug injection, measured immediately after injection 3. Pain from speculum insertion, measured immediately after insertion 4. Pain with tenaculum placement, measured immediately after placement 5. Pain with uterine sounding, measured immediately after removal of the sound 6. Pain at 5 minutes after placement of the intrauterine device 7. Pain at 15 minutes after placement of the intrauterine device
Outcome measures
| Measure |
Placebo With 1cc Normal Saline IM
n=8 Participants
If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection
|
Toradol, 30mg in 1cc IM
n=8 Participants
If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume
|
|---|---|---|
|
Nulliparous Patients - Subgroup Analysis
1) Anticipated pain
|
2.8 cm
Interval 0.8 to 5.4
|
3.6 cm
Interval 2.0 to 5.5
|
|
Nulliparous Patients - Subgroup Analysis
2) Pain with injection
|
1.8 cm
Interval 0.7 to 3.4
|
1.2 cm
Interval 0.8 to 2.7
|
|
Nulliparous Patients - Subgroup Analysis
3) Speculum insertion
|
2.3 cm
Interval 1.0 to 4.5
|
1.5 cm
Interval 0.3 to 3.1
|
|
Nulliparous Patients - Subgroup Analysis
4) Tenaculum placement
|
6.3 cm
Interval 3.7 to 7.3
|
4.3 cm
Interval 2.2 to 7.1
|
|
Nulliparous Patients - Subgroup Analysis
5) Uterine sounding
|
8.4 cm
Interval 6.6 to 9.2
|
6.0 cm
Interval 3.9 to 6.7
|
|
Nulliparous Patients - Subgroup Analysis
6) Pain with IUD placement
|
8.1 cm
Interval 7.4 to 9.0
|
5.4 cm
Interval 5.0 to 7.4
|
|
Nulliparous Patients - Subgroup Analysis
7) 5 min after placement
|
3.7 cm
Interval 2.3 to 4.8
|
2.7 cm
Interval 1.5 to 3.3
|
|
Nulliparous Patients - Subgroup Analysis
8) 15 min after placement
|
4.8 cm
Interval 3.0 to 6.9
|
1.8 cm
Interval 0.2 to 3.2
|
SECONDARY outcome
Timeframe: assessed at 15 minutes after IUD insertionQuestions assessed in multiple choice format: 1. Side effects 2. injection site pain 3. overall satisfaction with IUD insertion experience 4. would they still recommend IUD placement to a friend? 5. significant pain for which they desired acetaminophen prior to leaving the office?
Outcome measures
| Measure |
Placebo With 1cc Normal Saline IM
n=34 Participants
If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection
|
Toradol, 30mg in 1cc IM
n=33 Participants
If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume
|
|---|---|---|
|
Post-insertion Patient Questionnaire
Reported side effects
|
12 participants
|
8 participants
|
|
Post-insertion Patient Questionnaire
Injection site pain - just as bad/worse than IUD
|
8 participants
|
6 participants
|
|
Post-insertion Patient Questionnaire
Satisfied or very satisfied with overall IUD proc
|
30 participants
|
31 participants
|
|
Post-insertion Patient Questionnaire
Recommend IUD to a friend
|
28 participants
|
30 participants
|
|
Post-insertion Patient Questionnaire
Desires additional pain medication
|
16 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Immediately after IUD placement, on average within 1 hourThe provider will be asked to fill out a multiple choice format questionnaire: 1. what level training are you? 2. which IUD was inserted? 3. what was the purpose of IUD placement? 4. what was the position of the uterus? 5. did the IUD placement process require cervical dilation? 6. were you able to complete the IUD insertion? 7. was there bleeding from the cervix that required more than 5 min to control? 8. were there any major complications with the IUD insertion? 9. did the patient take tylenol prior to leaving the office?
Outcome measures
| Measure |
Placebo With 1cc Normal Saline IM
n=34 Participants
If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.
Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection
|
Toradol, 30mg in 1cc IM
n=33 Participants
If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.
Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume
|
|---|---|---|
|
Post-insertion Provider Questionnaire
Level of training - PGY1
|
2 participants
|
5 participants
|
|
Post-insertion Provider Questionnaire
Level of training - PGY2
|
2 participants
|
13 participants
|
|
Post-insertion Provider Questionnaire
Level of training - PGY3
|
3 participants
|
6 participants
|
|
Post-insertion Provider Questionnaire
Level of training - PGY4
|
5 participants
|
6 participants
|
|
Post-insertion Provider Questionnaire
Level of training - Attending
|
1 participants
|
3 participants
|
|
Post-insertion Provider Questionnaire
IUD type - levonogestrel
|
22 participants
|
28 participants
|
|
Post-insertion Provider Questionnaire
IUD type - copper
|
12 participants
|
2 participants
|
|
Post-insertion Provider Questionnaire
Purpose of IUD - contraception
|
33 participants
|
32 participants
|
|
Post-insertion Provider Questionnaire
Purpose of IUD - AUB
|
1 participants
|
1 participants
|
|
Post-insertion Provider Questionnaire
Position of uterus - anteverted
|
19 participants
|
20 participants
|
|
Post-insertion Provider Questionnaire
Position of uterus - retroverted
|
6 participants
|
5 participants
|
|
Post-insertion Provider Questionnaire
Position of uterus - midpositioned
|
9 participants
|
8 participants
|
|
Post-insertion Provider Questionnaire
Cervical dilation needed
|
2 participants
|
2 participants
|
|
Post-insertion Provider Questionnaire
Able to complete the IUD placement
|
34 participants
|
33 participants
|
|
Post-insertion Provider Questionnaire
Significant bleeding
|
0 participants
|
2 participants
|
|
Post-insertion Provider Questionnaire
Major complications
|
0 participants
|
0 participants
|
|
Post-insertion Provider Questionnaire
Took acetaminophen prior to leaving the office
|
17 participants
|
7 participants
|
Adverse Events
Placebo With 1cc Normal Saline IM
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Toradol, 30mg in 1cc IM
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place