N/A
N=119
Naproxen for Pain Control With Intrauterine Device Insertion
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT02388191 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS) — 69; 66 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Naproxen sodium (Drug); Placebo tablet (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Planned Parenthood League of Massachusetts
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain at Time of IUD Insertion Using a 10 cm (100 mm) Visual Analog Scale (VAS) |
69; 66 | — |
| SECONDARY Pain With Tenaculum Placement Using a 10cm (100 mm) Visual Analog Scale (VAS) |
37.3; 31.8 | — |
| SECONDARY Pain With Uterine Sounding Using a 10cm (100 mm) Visual Analog Scale (VAS) |
59.8; 58 | — |
| SECONDARY Pain 5 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS) |
16.5; 26 | — |
| SECONDARY Pain 15 Minutes After IUD Insertion Using a 10cm (100 mm) Visual Analog Scale (VAS) |
12.8; 24 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02388191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.