N/A
N=200
Cervical Lidocaine for Intrauterine Device Insertion Pain
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01411995 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Pain Score Assessed Immediately Following IUD Insertion — 5; 6 units on visual analog scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 2% lidocaine gel (Drug); Water based lubricant (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Washington University School of Medicine
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Score Assessed Immediately Following IUD Insertion |
5; 6 | — |
Summary
The aim of this study is to evaluate intracervical lidocaine gel as a means to decrease pain associated with intrauterine device (IUD) insertion. They will be randomized to either placebo (inert water based lubricating gel) or 2% lidocaine gel to be placed intracervically via angio-catheter just before intrauterine device insertion. Anticipated pain scores will be assessed using a visual analog scale prior to insertion. Using the same pain scale, patients will again be asked at the end of the procedure to rate their pain.
Eligibility Criteria
Inclusion Criteria
- age 18-45 yrs
- selecting intrauterine device contraception
- able and willing to consent
Exclusion Criteria
- non-English speaking
- current intrauterine device use
- expulsion of intrauterine device within 2 weeks
- allergy to lidocaine or water based lubricant
Data sourced from ClinicalTrials.gov (NCT01411995). 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.