Trial Outcomes & Findings for Naproxen for Pain Control With Intrauterine Device Insertion (NCT NCT02388191)
NCT ID: NCT02388191
Last Updated: 2017-06-22
Results Overview
Pain at time of IUD insertion will be measured immediately upon completion of IUD insertion using a 100 mm visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.
COMPLETED
NA
119 participants
Immediately after IUD insertion is complete
2017-06-22
Participant Flow
Participant milestones
| Measure |
Naproxen Sodium
550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1
|
Placebo
Placebo
Placebo tablet
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
60
|
|
Overall Study
COMPLETED
|
58
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
Naproxen Sodium
550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1
|
Placebo
Placebo
Placebo tablet
|
|---|---|---|
|
Overall Study
Patient did not receive IUD
|
1
|
0
|
Baseline Characteristics
Naproxen for Pain Control With Intrauterine Device Insertion
Baseline characteristics by cohort
| Measure |
Naproxen Sodium
n=58 Participants
550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1
|
Placebo
n=60 Participants
Placebo
Placebo tablet
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.2 years
STANDARD_DEVIATION 3.9 • n=99 Participants
|
24.3 years
STANDARD_DEVIATION 4.2 • n=107 Participants
|
23.86 years
STANDARD_DEVIATION 4.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
African American or black
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White or European American
|
43 Participants
n=99 Participants
|
50 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiracial
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Marital status
Married
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Marital status
Single
|
51 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
105 Participants
n=206 Participants
|
|
Marital status
Other
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Highest level of education
High school or high school equivalency
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Highest level of education
Some college or 2 year college
|
25 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Highest level of education
4 year college or Bachelor's degree
|
23 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Highest level of education
Graduate or professional school
|
5 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Highest level of education
Other
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Diagnosed with chronic pain condition (yes)
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Diagnosed with depression (yes)
|
14 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Baseline stress, self-report
|
4 units on a scale
n=99 Participants
|
4 units on a scale
n=107 Participants
|
4 units on a scale
n=206 Participants
|
|
Baseline sadness, self-report
|
2 units on a scale
n=99 Participants
|
3 units on a scale
n=107 Participants
|
2 units on a scale
n=206 Participants
|
|
Baseline anxiety, self-report
|
3 units on a scale
n=99 Participants
|
4 units on a scale
n=107 Participants
|
3.5 units on a scale
n=206 Participants
|
|
Baseline pain tolerance, self report
|
3 units on a scale
n=99 Participants
|
4 units on a scale
n=107 Participants
|
3 units on a scale
n=206 Participants
|
|
Expected pain for IUD insertion
|
45.5 units on a scale
n=99 Participants
|
50.3 units on a scale
n=107 Participants
|
49.3 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: Immediately after IUD insertion is completePain at time of IUD insertion will be measured immediately upon completion of IUD insertion using a 100 mm visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.
Outcome measures
| Measure |
Naproxen Sodium
n=58 Participants
550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1
|
Placebo
n=60 Participants
Placebo
Placebo tablet
|
|---|---|---|
|
Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS)
|
69 units on a scale
Interval 52.5 to 80.5
|
66 units on a scale
Interval 50.0 to 82.0
|
SECONDARY outcome
Timeframe: Immediately after tenaculum is placed on cervixPain with tenaculum placement will be measured immediately after tenaculum is placed on the cervix using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.
Outcome measures
| Measure |
Naproxen Sodium
n=58 Participants
550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1
|
Placebo
n=60 Participants
Placebo
Placebo tablet
|
|---|---|---|
|
Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS)
|
37.3 units on a scale
Interval 20.0 to 55.0
|
31.8 units on a scale
Interval 17.0 to 60.0
|
SECONDARY outcome
Timeframe: Immediately after uterine soundingPain with uterine sounding will be measured immediately after uterine sounding using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.
Outcome measures
| Measure |
Naproxen Sodium
n=58 Participants
550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1
|
Placebo
n=60 Participants
Placebo
Placebo tablet
|
|---|---|---|
|
Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS)
|
59.8 units on a scale
Interval 45.0 to 75.0
|
58 units on a scale
Interval 39.0 to 68.0
|
SECONDARY outcome
Timeframe: Five minutes after IUD insertion is completePain 5 minutes after IUD insertion will occur five minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.
Outcome measures
| Measure |
Naproxen Sodium
n=58 Participants
550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1
|
Placebo
n=60 Participants
Placebo
Placebo tablet
|
|---|---|---|
|
Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)
|
16.5 units on a scale
Interval 4.5 to 29.0
|
26 units on a scale
Interval 14.0 to 39.0
|
SECONDARY outcome
Timeframe: Fifteen minutes after IUD insertion is completePain 15 minutes after IUD insertion will occur 15 minutes after IUD insertion is complete using a 10cm (100 mm) visual analog scale (VAS). Patients are presented with a 100 mm line. On one end of the line, the anchor is "0 = No pain". On the opposite end of the line, the anchor is "10 = worst pain possible". Subjects are asked: "Where 0 is no pain and 10 is the worst pain possible, please record your pain on the scale below." Research staff measure the distance between the "0 = No pain" anchor and the mark made by the patient (in mm) to score the measure.
Outcome measures
| Measure |
Naproxen Sodium
n=58 Participants
550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1
|
Placebo
n=60 Participants
Placebo
Placebo tablet
|
|---|---|---|
|
Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)
|
12.8 units on a scale
Interval 5.0 to 31.0
|
24 units on a scale
Interval 11.0 to 38.0
|
Adverse Events
Naproxen Sodium
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Naproxen Sodium
n=58 participants at risk
550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1
|
Placebo
n=60 participants at risk
Placebo
Placebo tablet
|
|---|---|---|
|
General disorders
Vasovagal episode
|
3.4%
2/58 • Number of events 2
|
5.0%
3/60 • Number of events 3
|
Additional Information
Principal Investigator
Planned Parenthood League of Massachusetts
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place