N/A
N=80
Nitrous Oxide for Pain Management of Intrauterine Device (IUD) Insertion
Contraception
Bottom Line
View on ClinicalTrials.gov: NCT02391714 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcome: Primary: Mean Maximum Procedural Pain Scores — 55.3; 54.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- IUD insertion (Procedure); Povidone-Iodine (Drug); Chlorhexidine (Drug); Oxygen (Other); Nitrous oxide (Other)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- Female
- Sponsor
- University of New Mexico
- Primary completion
- Aug 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Maximum Procedural Pain Scores |
55.3; 54.3 | — |
| SECONDARY Patient Satisfaction With Over-all Pain Control With IUD Insertion - VAS |
60.3; 66.0 | — |
| SECONDARY Baseline Mean Pain Scores |
1.9; 2.4 | — |
Summary
The purpose of this study is to determine whether Nitrous Oxide is effective in achieving pain control and satisfaction among nulliparous women getting the intrauterine device (IUD).
Eligibility Criteria
Inclusion Criteria
- Age >18 OR between the ages of 12-17 with a parent/legal guardian who can consent
- English speaking
- Desires a Mirena® or ParaGard® IUD
- Nulliparous woman
- Can use laughing gas
- Has not taken narcotic pain medications prior to procedure
Exclusion Criteria
- Currently pregnant
- If you have been pregnant before, pregnancy lasting longer than 19 weeks, 6 days
- Less than 4 weeks have elapsed from the end of a spontaneous abortion or medical abortion.
- Desires Skyla® IUD
- Pelvic Inflammatory Disease in the last 3 months
- Current mucopurulent discharge
- Uterine anomaly that distorts the uterine cavity
- Known uterine fibroid with disruption of the uterine cavity
- Copper allergy/Wilson's disease (for ParaGard®)
- Current cervical or uterine cancer
- Inability to breathe through the nose
- Significant active upper airway infection
Data sourced from ClinicalTrials.gov (NCT02391714). 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.