Nitrous Oxide for Pain Management of First Trimester Surgical Abortion

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nitrous Oxide for Pain Management of First Trimester Surgical Abortion

Conditions
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Abortion in First Trimester

Intervention / Treatment
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* Other: Nitrous oxide administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nitrous oxide administration<br>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. | Other: Nitrous oxide administration<br>* 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.<br>|
| No Intervention: Standard care group<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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. | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nitrous oxide, pain