Using a cooling spray to reduce pain during gynecology procedures
Vapocoolant Application for Pain Reduction During Office-based Gynecologic Procedures: a Randomized Controlled Trial (VAPOR)
This study is testing if a cooling spray can help reduce pain for women during certain gynecological procedures.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 98 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Queen's Medical Center Academic / other |
| Locations | 1 site (Honolulu, Hawaii) |
| Trial ID | NCT06227052 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Num vapocoolant spray in reducing pain associated with paracervical blocks during gynecological procedures. Eligible patients will be randomized to receive either the vapocoolant spray or a placebo just before the procedure. The study aims to determine if the cooling effect of the spray can significantly decrease pain levels experienced during the paracervical block. Informed consent will be obtained from all participants prior to their involvement in the study.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 18 and older who are undergoing a gynecological procedure that requires a paracervical block.
Not a fit: Patients who require narcotics, anxiolytics, or sedation for their procedure, or those with allergies to the study components, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to a more comfortable experience for patients undergoing gynecological procedures requiring a paracervical block.
How similar studies have performed: While the use of vapocoolant sprays is a novel approach in this specific context, similar studies have shown promise in pain reduction techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years of age or older Undergoing a procedure requiring paracervical block English-speaking Able and willing to sign the informed consent form and agree to terms of the study Exclusion Criteria: * Required or requested narcotics, anxiolytics, IV sedation, or general anesthesia for the procedure Declines or has a contraindication/allergy to ibuprofen Previously received vapocoolant spray in a medical setting Contraindications or allergies to lidocaine for paracervical block or vapocoolant spray components (1,1,3,3-pentafluoropropaine or 1,1,1,2-tetrafluroethane)
Where this trial is running
Honolulu, Hawaii
- Queens Medical Center POB1 Clinic 1004 — Honolulu, Hawaii, United States (Recruiting)
Study contacts
- Study coordinator: Lule Rault, MD
- Email: crault@hawaii.edu
- Phone: 1-808-375-3785
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.