Nitrous Oxide for Pain Management of First Trimester Surgical Abortion

Abortion in First Trimester Clinical Trial

— NAB  

Official title:

Nitrous Oxide for Pain Management of First Trimester Surgical Abortion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096575
• Other study ID #: UNMHSC12-313
• Status: Completed
• Phase: N/A
• First received: March 20, 2014
• Last updated: April 15, 2016
• Start date: August 2012
• Est. completion date: April 2015

Study information

• Verified date: April 2016
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Abortion in First Trimester

Intervention

Other:
• Nitrous oxide administration
All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. The NO group will get two placebo pills and the standard care group will get one 5/325 mg Vicodin, and 1 mg of Ativan 30 minutes before the procedure. The standard care group will get oxygen intraoperatively. NO or oxygen will be administered via a scented nasal mask to blind patients to the intervention. All patients will get local anesthesia via a standardized PCB.

Locations

Country	Name	City	State
United States	University of New Mexico Health Sciences Center	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Pain Score for Mean Maximum Procedural Pain	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	Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure	No
Secondary	Visual Analog Scale Score for Baseline Pain	A quantitative assessment of pain prior to the procedure. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain	Baseline pain assessment on average within 30 minutes before procedure	No
Secondary	Visual Analog Scale for Post-procedure Pain	A quantitative assessment of post-procedure pain. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain	Visual analog scale administered on average 20 minutes after procedure completed	No
Secondary	Pain Management Satisfaction	Quantitative assessment of pain management. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain	Visual analog scale for satisfaction administered on average within 20 minutes after procedure completion.	No
Secondary	Visual Analog Scale to Measure Anticipated Pain.	Anticipated pain is assessed before the procedure. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain	Anticipated pain assessed on average within 30 minutes before procedure	No