Nitrous Oxide for Pain Management of First Trimester Surgical Abortion

Not Applicable

Completed

• Conditions: Abortion in First Trimester

• Registration Number: NCT02096575
• Lead Sponsor: University of New Mexico

Brief Summary

The purpose of this research is to study the effect of nitrous oxide on pain felt by women having a surgical termination at less than 11 weeks compared to pain felt by women receiving oral pain medications.

Detailed Description

This study has important implications in the field of pain management for surgical abortion. While NO is administered in some outpatient clinics for surgical abortion, its effect on pain has not been systematically studied in a randomized controlled trial in women undergoing first trimester surgical abortion under local/oral analgesia. Expanding pain management options for women undergoing abortion confers significant public health benefits.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2014-03-20
• Study First Submitted QC: 2014-03-23
• Study First Posted: 2014-03-26
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Results First Submitted: 2016-02-12
• Results First Submitted QC: 2016-02-12
• Results First Posted: 2016-03-11
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-15
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

• 18 years old or older,
• elective pregnancy termination at gestational age of less than 11 weeks,
• speak English
• candidate for an in-clinic procedure.
• desire local anesthesia, ibuprofen, Vicodin and Ativan (the usual treatment in our clinic) for managing pain

Exclusion Criteria

• no medical problems preventing the use of nitrous oxide
• no allergies to nitrous oxide, lidocaine, vasopressin, ibuprofen, Vicodin or Ativan
• significant active upper respiratory infection
• chronic obstructive pulmonary disease (COPD)
• intoxication
• use of street drugs

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Pain Score for Mean Maximum Procedural Pain	Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure	The primary outcome of this study is to evaluate the difference in mean maximum pain experienced during the procedure between groups as assessed 5 minutes after the procedure is completed.; Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale Score for Baseline Pain	Baseline pain assessment on average within 30 minutes before procedure	A quantitative assessment of pain prior to the procedure. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain
Visual Analog Scale for Post-procedure Pain	Visual analog scale administered on average 20 minutes after procedure completed	A quantitative assessment of post-procedure pain. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain
Pain Management Satisfaction	Visual analog scale for satisfaction administered on average within 20 minutes after procedure completion.	Quantitative assessment of pain management. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain
Visual Analog Scale to Measure Anticipated Pain.	Anticipated pain assessed on average within 30 minutes before procedure	Anticipated pain is assessed before the procedure. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain

Trial Locations

Locations (1)

University of New Mexico Health Sciences Center; 🇺🇸 Albuquerque, New Mexico, United States