Nitrous Oxide for Pain Management of First Trimester Surgical Abortion

N/ACompletedNCT02096575

University of New Mexico140 enrolled

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

140

Conditions

Abortion in First Trimester

Interventions

Nitrous oxide administrationOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, United States

Outcomes

Primary Outcomes

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

Time frame: Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure

Secondary Outcomes

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

Time frame: Baseline pain assessment on average within 30 minutes before procedure

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

Time frame: Visual analog scale administered on average 20 minutes after procedure completed

Pain Management Satisfaction

Quantitative assessment of pain management. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain

Time frame: Visual analog scale for satisfaction administered on average within 20 minutes after procedure completion.

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

Time frame: Anticipated pain assessed on average within 30 minutes before procedure

Data from ClinicalTrials.gov

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