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Completed

NCT Number: NCT02096575

Nitrous Oxide for Pain Management of First Trimester Surgical Abortion

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.

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Key information

Conditions

Abortion in First Trimester Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitrous oxide administration

Other

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.

Primary outcomes

  1. Visual Analog Pain Score for Mean Maximum Procedural Pain

    Time frame: 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 outcomes

  1. Visual Analog Scale Score for Baseline Pain

    Time frame: 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

  2. Visual Analog Scale for Post-procedure Pain

    Time frame: 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

  3. Pain Management Satisfaction

    Time frame: 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

  4. Visual Analog Scale to Measure Anticipated Pain.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Registry information

Acronym: NAB

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2014
Registry last updated
Apr 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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