Clinical trial NCT02096575: Nitrous Oxide for Pain Management of First Trimester Surgical Abortion
Official title: Nitrous Oxide for Pain Management of First Trimester Surgical Abortion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion in First Trimester
Keywords: nitrous oxide
pain
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2014-03-26
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Pain Score for Mean Maximum Procedural Pain
timeFrame: Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure
Secondary outcomes:
measure: Visual Analog Scale Score for Baseline Pain
timeFrame: Baseline pain assessment on average within 30 minutes before procedure
measure: Visual Analog Scale for Post-procedure Pain
timeFrame: Visual analog scale administered on average 20 minutes after procedure completed
measure: Pain Management Satisfaction
timeFrame: Visual analog scale for satisfaction administered on average within 20 minutes after procedure completion.
measure: Visual Analog Scale to Measure Anticipated Pain.
timeFrame: Anticipated pain assessed on average within 30 minutes before procedure
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Health Sciences Center
state: New Mexico
Study officials:
affiliation: University of New Mexico Health Sciences Center
name: Rameet H. Singh, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Singh RH, Espey E, Carr S, Pereda B, Ogburn T, Leeman L. Nitrous oxide for pain management of first trimester surgical abortion -- a randomized controlled pilot study. Contraception. 2015 Feb;91(2):164-6. doi: 10.1016/j.contraception.2014.09.013. Epub 2014 Oct 22.