Abortion in First Trimester
Conditions
Keywords
nitrous oxide, pain
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.
Interventions
OTHERNitrous 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.
Sponsors
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Pain Score for Mean Maximum Procedural Pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale Score for Baseline Pain | 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 | 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 | 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. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Nitrous oxide administration | 68 |
| 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. | 67 |
| Total | 135 |
Baseline characteristics
| Characteristic | Standard Care Group | Nitrous Oxide Administration | Total |
|---|---|---|---|
| Age, Customized | 26.03 years | 26.72 years | 26.38 years |
| Race/Ethnicity, Customized Asian | 3 participants | 0 participants | 3 participants |
| Race/Ethnicity, Customized Bi or Multiracial | 4 participants | 5 participants | 9 participants |
| Race/Ethnicity, Customized Black or African American | 3 participants | 2 participants | 5 participants |
| Race/Ethnicity, Customized Hispanic/ Latino | 5 participants | 9 participants | 14 participants |
| Race/Ethnicity, Customized Native American/ Alaska Native | 4 participants | 12 participants | 16 participants |
| Race/Ethnicity, Customized Native Hawaiian/ Pacific Islander | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Other | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Unknown or Not reported | 3 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized White | 45 participants | 37 participants | 82 participants |
| Region of Enrollment United States | 67 participants | 68 participants | 135 participants |
| Sex: Female, Male Female | 67 Participants | 68 Participants | 135 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 68 | 0 / 67 |
| serious Total, serious adverse events | 0 / 68 | 0 / 67 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nitrous Oxide Administration | Visual Analog Pain Score for Mean Maximum Procedural Pain | 54.37 units on a scale |
| Standard Care Group | Visual Analog Pain Score for Mean Maximum Procedural Pain | 60.48 units on a scale |
Secondary
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nitrous Oxide Administration | Pain Management Satisfaction | 69.3382 units on a scale | Standard Deviation 28.3789 |
| Standard Care Group | Pain Management Satisfaction | 61.5373 units on a scale | Standard Deviation 30.3536 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nitrous Oxide Administration | Visual Analog Scale for Post-procedure Pain | 26.68 units on a scale | Standard Deviation 22.28 |
| Standard Care Group | Visual Analog Scale for Post-procedure Pain | 25.96 units on a scale | Standard Deviation 24.33 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nitrous Oxide Administration | Visual Analog Scale Score for Baseline Pain | 4.7426 units on a scale | Standard Deviation 12.884 |
| Standard Care Group | Visual Analog Scale Score for Baseline Pain | 4.4388 units on a scale | Standard Deviation 11.7748 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nitrous Oxide Administration | Visual Analog Scale to Measure Anticipated Pain. | 56.1544 units on a scale | Standard Deviation 24.4817 |
| Standard Care Group | Visual Analog Scale to Measure Anticipated Pain. | 50.3104 units on a scale | Standard Deviation 21.7043 |