Pain Uterus
Conditions
Brief summary
Intranasal fentanyl has been found to be safe and effective in the reduction of pain among pediatric and adult populations. The investigators hypothesize that patients who receive 100 mcg of intranasal fentanyl for pain control before first-trimester uterine aspiration will report lower pain scores than those who receive placebo. The investigators will test this hypothesis using a randomized, double-blind, placebo-controlled trial comparing pain reported during uterine aspiration between patients who receive either intranasal fentanyl or intranasal saline prior to the procedure.
Interventions
DRUGFentanyl
100 mcg of intranasal fentanyl, 50 mcg/ mL in each nostril via mucosal atomizer 15 minutes prior to procedure start
DRUGplacebo
1 mL of sterile saline in each nostril via mucosal atomizer 15 minutes prior to procedure start
Sponsors
Society of Family Planning
University of Hawaii
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Seeking office based uterine aspiration * Gestational age at 14 weeks or less * Age 14 years or older with parental consent to participate in this research study if 14-17 years old * Able to read, speak, and understand English * Ability to understand materials and consent forms
Exclusion criteria
* Seeking medical abortion, operating room based surgical abortion, or operating room based miscarriage management * Gestational age greater than 14 weeks * Age less than 14 years old * Inability to read, speak, and understand English * Current incarceration * Weight less than 40kg * Self-reported or documentation of significant cardiopulmonary disease * Self-reported or documentation of alcohol or substance dependence or abuse * Contraindications, relative contraindication to fentanyl use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain during uterine aspiration | During uterine aspiration or immediately after uterine aspiration | Self reported on 100 mm VAS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction with procedural pain control | approximately 15 minutes after procedure ends | Self reported on 100 mm VAS |
| Post-procedural pain | approximately 15 minutes after procedure end | Self reported on 100 mm VAS |
Countries
United States
Outcome results
None listed