Contraception
Conditions
Keywords
Contraception, Naproxen, Intrauterine devices, Pain Control
Brief summary
The purpose of this study is: 1. To evaluate whether 550 mg of naproxen sodium reduces pain scores with IUD insertion on a 0-10cm visual analogue scale compared to placebo (primary outcome). 2. To evaluate whether 550 mg of naproxen sodium reduces pain scores with tenaculum placement, uterine sounding and post-procedurally on a 0-10 cm visual analog scale compared to placebo (secondary outcomes). 3. To establish if prophylactic naproxen sodium is acceptable for routine use prior to IUD insertion. Hypothesis: The administration of naproxen sodium, 550mg orally, 1 hour prior to IUD insertion will lead to a reduction in pain scores associated with IUD insertion compared to placebo.
Interventions
DRUGNaproxen sodium
550 mg, oral, on day 1. Number of Cycles: 1
OTHERPlacebo tablet
Sponsors
Planned Parenthood League of Massachusetts
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 years or older * Premenopausal * Presenting for insertion of any IUD type (i.e. Mirena, Paragard, Skyla) * English-speaking or non-English speaking with appropriate translator available
Exclusion criteria
* Currently pregnant or pregnant within the last 4 weeks * Not eligible for IUD insertion per PPLM's clinical protocols * Presenting for IUD removal and reinsertion * Any diagnosis of chronic pain (including fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis) * Pain medications taken within 12 hours of enrollment * Misoprostol usage within 24 hours of enrollment * Any known allergy or contraindication to non-steroidal anti-inflammatory drugs (including active renal disease, active hepatic disease, gastric ulcer disease or gastritis, and bleeding disorders)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS) | Immediately after IUD insertion is complete | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS) | Immediately after tenaculum is placed on cervix | Pain 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. |
| Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS) | Immediately after uterine sounding | Pain 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. |
| Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS) | Five minutes after IUD insertion is complete | Pain 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. |
| Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS) | Fifteen minutes after IUD insertion is complete | Pain 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Naproxen Sodium 550 mg naproxen sodium
Naproxen sodium: 550 mg, oral, on day 1. Number of Cycles: 1 | 58 |
| Placebo Placebo
Placebo tablet | 60 |
| Total | 118 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patient did not receive IUD | 1 | 0 |
Baseline characteristics
| Characteristic | Naproxen Sodium | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 23.2 years STANDARD_DEVIATION 3.9 | 24.3 years STANDARD_DEVIATION 4.2 | 23.86 years STANDARD_DEVIATION 4.1 |
| Baseline anxiety, self-report | 3 units on a scale | 4 units on a scale | 3.5 units on a scale |
| Baseline pain tolerance, self report | 3 units on a scale | 4 units on a scale | 3 units on a scale |
| Baseline sadness, self-report | 2 units on a scale | 3 units on a scale | 2 units on a scale |
| Baseline stress, self-report | 4 units on a scale | 4 units on a scale | 4 units on a scale |
| Diagnosed with chronic pain condition (yes) | 2 Participants | 1 Participants | 3 Participants |
| Diagnosed with depression (yes) | 14 Participants | 11 Participants | 25 Participants |
| Expected pain for IUD insertion | 45.5 units on a scale | 50.3 units on a scale | 49.3 units on a scale |
| Highest level of education 4 year college or Bachelor's degree | 23 Participants | 22 Participants | 45 Participants |
| Highest level of education Graduate or professional school | 5 Participants | 9 Participants | 14 Participants |
| Highest level of education High school or high school equivalency | 5 Participants | 4 Participants | 9 Participants |
| Highest level of education Other | 0 Participants | 2 Participants | 2 Participants |
| Highest level of education Some college or 2 year college | 25 Participants | 23 Participants | 48 Participants |
| Marital status Married | 3 Participants | 1 Participants | 4 Participants |
| Marital status Other | 4 Participants | 5 Participants | 9 Participants |
| Marital status Single | 51 Participants | 54 Participants | 105 Participants |
| Race/Ethnicity, Customized African American or black | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 6 Participants | 6 Participants | 12 Participants |
| Race/Ethnicity, Customized Multiracial | 3 Participants | 2 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 5 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized White or European American | 43 Participants | 50 Participants | 93 Participants |
| Sex: Female, Male Female | 58 Participants | 60 Participants | 118 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 | 2 / 58 | 3 / 60 |
| serious Total, serious adverse events | 0 / 58 | 0 / 60 |
Outcome results
Primary
Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS)
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.
Time frame: Immediately after IUD insertion is complete
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Naproxen Sodium | Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS) | 69 units on a scale |
| Placebo | Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS) | 66 units on a scale |
Secondary
Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)
Pain 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.
Time frame: Fifteen minutes after IUD insertion is complete
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Naproxen Sodium | Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS) | 12.8 units on a scale |
| Placebo | Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS) | 24 units on a scale |
Secondary
Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS)
Pain 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.
Time frame: Five minutes after IUD insertion is complete
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Naproxen Sodium | Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS) | 16.5 units on a scale |
| Placebo | Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS) | 26 units on a scale |
Secondary
Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS)
Pain 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.
Time frame: Immediately after tenaculum is placed on cervix
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Naproxen Sodium | Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS) | 37.3 units on a scale |
| Placebo | Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS) | 31.8 units on a scale |
Secondary
Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS)
Pain 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.
Time frame: Immediately after uterine sounding
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Naproxen Sodium | Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS) | 59.8 units on a scale |
| Placebo | Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS) | 58 units on a scale |