Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration

Study Overview
=================
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.

Official Title
-----------------
Intranasal Fentanyl for Pain Control During First-Trimester Uterine Aspiration: A Randomized Controlled Trial

Conditions
-----------------
Pain Uterus

Intervention / Treatment
-----------------
* Drug: Fentanyl
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fentanyl<br> | Drug: Fentanyl<br>* 100 mcg of intranasal fentanyl, 50 mcg/ mL in each nostril via mucosal atomizer 15 minutes prior to procedure start<br>|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* 1 mL of sterile saline in each nostril via mucosal atomizer 15 minutes prior to procedure start<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during uterine aspiration | Self reported on 100 mm VAS | During uterine aspiration or immediately after uterine aspiration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with procedural pain control | Self reported on 100 mm VAS | approximately 15 minutes after procedure ends | 
| Post-procedural pain | Self reported on 100 mm VAS | approximately 15 minutes after procedure end |