Nitrous Oxide for Pain Management of First Trimester Surgical Abortion

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 2015

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Nitrous oxide administration
    • All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin. In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient’s nose and the nitrous oxide will be administered continuously.
  • No Intervention: Standard care group
    • All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin. The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of New Mexico
  • Provider of Information About this Clinical Study
    • Principal Investigator: Rameet Singh, Assistant Professor – University of New Mexico
  • Overall Official(s)
    • Rameet H. Singh, MD, MPH, Principal Investigator, University of New Mexico Health Sciences Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.