Trial Outcomes & Findings for Nitrous Oxide for Pain Management of First Trimester Surgical Abortion (NCT NCT02096575)
NCT ID: NCT02096575
Last Updated: 2016-04-19
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
140 participants
Primary outcome timeframe
Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedure
Results posted on
2016-04-19
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
Excluded
Participants that were withdrawn from the study after consent
|
|---|---|---|---|
|
Overall Study
STARTED
|
68
|
67
|
5
|
|
Overall Study
COMPLETED
|
68
|
67
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nitrous Oxide for Pain Management of First Trimester Surgical Abortion
Baseline characteristics by cohort
| Measure |
Nitrous Oxide Administration
n=68 Participants
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
|
Standard Care Group
n=67 Participants
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.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
26.72 years
n=5 Participants
|
26.03 years
n=7 Participants
|
26.38 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American/ Alaska Native
|
12 participants
n=5 Participants
|
4 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/ Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/ Latino
|
9 participants
n=5 Participants
|
5 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
37 participants
n=5 Participants
|
45 participants
n=7 Participants
|
82 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Bi or Multiracial
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not reported
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
67 participants
n=7 Participants
|
135 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Mean maximum pain experienced during the procedure and assessed 5 minutes after the procedureThe 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
Outcome measures
| Measure |
Nitrous Oxide Administration
n=68 Participants
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.
|
Standard Care Group
n=67 Participants
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.
|
|---|---|---|
|
Visual Analog Pain Score for Mean Maximum Procedural Pain
|
54.37 units on a scale
Interval 3.0 to 100.0
|
60.48 units on a scale
Interval 1.0 to 100.0
|
SECONDARY outcome
Timeframe: Baseline pain assessment on average within 30 minutes before procedureA quantitative assessment of pain prior to the procedure. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain
Outcome measures
| Measure |
Nitrous Oxide Administration
n=68 Participants
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.
|
Standard Care Group
n=67 Participants
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.
|
|---|---|---|
|
Visual Analog Scale Score for Baseline Pain
|
4.7426 units on a scale
Standard Deviation 12.884
|
4.4388 units on a scale
Standard Deviation 11.7748
|
SECONDARY outcome
Timeframe: Visual analog scale administered on average 20 minutes after procedure completedA quantitative assessment of post-procedure pain. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain
Outcome measures
| Measure |
Nitrous Oxide Administration
n=68 Participants
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.
|
Standard Care Group
n=67 Participants
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.
|
|---|---|---|
|
Visual Analog Scale for Post-procedure Pain
|
26.68 units on a scale
Standard Deviation 22.28
|
25.96 units on a scale
Standard Deviation 24.33
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Nitrous Oxide Administration
n=68 Participants
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.
|
Standard Care Group
n=67 Participants
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.
|
|---|---|---|
|
Pain Management Satisfaction
|
69.3382 units on a scale
Standard Deviation 28.3789
|
61.5373 units on a scale
Standard Deviation 30.3536
|
SECONDARY outcome
Timeframe: Anticipated pain assessed on average within 30 minutes before procedureAnticipated pain is assessed before the procedure. Pain was assessed using the Visual Analog Scale (VAS). 0 = no pain, 100 = maximum pain
Outcome measures
| Measure |
Nitrous Oxide Administration
n=68 Participants
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.
|
Standard Care Group
n=67 Participants
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.
|
|---|---|---|
|
Visual Analog Scale to Measure Anticipated Pain.
|
56.1544 units on a scale
Standard Deviation 24.4817
|
50.3104 units on a scale
Standard Deviation 21.7043
|
Adverse Events
Nitrous Oxide Administration
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michel Paves, HS Research Specialist
U of New Mexico - Dept of OBGYN/Family Planning
Phone: 505-272-9703
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place