N/A
Completed N=72
Nitrous Oxide for Pain Management During In-office Transcervical Sterilization
Contraception · Inhalation of Nitrous Oxide
Source: ClinicalTrials.gov NCT02312739 ↗
Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcomePrimary: Change From Baseline in Pain Scale Measurement During and After the Procedure — 1.1; 2.5; 15.6; 15.4 units on a scale
Summary
This is a randomized, double blind study that aims to measure the difference in maximum pain experienced during in-office transcervical sterilization (Essure®) for women receiving either inhaled nitrous oxide or standard oral analgesia (Vicodin and Lorazepam) with inhaled oxygen.
The investigators hypothesize that inhaled nitrous oxide will reduce the pain experienced more than standard oral medications in women undergoing in-office transcervical sterilization.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Pain Scale Measurement During and After the Procedure |
1.1; 2.5; 15.6; 15.4; 40.7; 14.9 | — |
| PRIMARY Pain Scale Measurement - Maximum Pain Experienced |
54.5; 22.8 | — |
| SECONDARY Change From Baseline in Patient Anxiety Scale After the Procedure |
8.4; 9.4; 8.5; 8.2 | — |
| SECONDARY Patient Satisfaction (5-point Likert Scale) |
77; 85; 23; 15 | — |
| SECONDARY Provider Ease of Insertion (0-100mm VAS) |
22.7; 19.8 | — |
Eligibility Criteria
Inclusion Criteria
- Premenopausal women desiring permanent sterilization and have chosen to proceed with a transcervical sterilization approach
- Speaks English or Spanish
- If relying on state or federal funding for sterilization, must have appropriate federal consents signed 30 days prior to the sterilization procedure
- Agrees to either a hormonal endometrial preparation prior to the procedure or schedule the procedure during the follicular phase (days 5 through 12) of their menstrual cycle
- Sexually active who agrees to contraception for 3 months post procedure, including condoms, followed by a hysterosalpingogram (HSG) for confirmation of fallopian tubal occlusion.
Exclusion Criteria
- With contraindications for nitrous oxide including: respiratory infection, chronic obstructive pulmonary disease (COPD), intoxication or use of street drugs, inability to breathe through their nose.
- Have taken narcotic pain medications prior to coming to their appointment
- Unsure about desire to end fertility
- History of pelvic inflammatory disease in the past 3 months
- Pregnancy or suspicion of pregnancy
- Delivery or termination of a pregnancy within the last 6 weeks
- Known allergy to contrast
- Uterine anomalies
- Previous tubal surgery
- Cervical or endometrial cancer
- Allergy to Vicodin, lorazepam, or lidocaine.
Data sourced from ClinicalTrials.gov (NCT02312739). 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. Informational only — not medical advice.