Pregnancy Termination in Second Trimester
Conditions
Keywords
nitrous, pain
Brief summary
This study is a multi-site, double-blinded, randomized, non-inferiority clinical trial of inhaled nitrous oxide with oxygen (N2O/O2) versus intravenous (IV) sedation, with fentanyl and midazolam, for pain management in adult women having a pregnancy termination procedure between 12 and 16 weeks gestational age.
Detailed description
This study will evaluate whether nitrous oxide is a feasible and acceptable alternative to IV sedation for pain management during early second trimester D&E. Primary endpoints will include maximum procedural pain using the visual analog scale (VAS) as well as satisfaction with anesthesia using the Iowa Satisfaction with Anesthesia Scale.
Interventions
DRUGNitrous Oxide
Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.
DRUGIV Saline
Sponsors
Society of Family Planning
University of Colorado, Denver
University of New Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years old or older * pregnancy termination at gestational age of 12-16 weeks * able to read and understand either English or Spanish * able to obtain reliable post-procedure transportation
Exclusion criteria
* contraindications to outpatient pregnancy termination * contraindications to nitrous oxide use (such as pernicious anemia, current treatment with bleomycin chemotherapy, active upper respiratory illness, or COPD) * intrauterine fetal demise * chronic narcotic use * known adverse reaction to nitrous oxide, Fentanyl, or Versed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Score for Maximum Procedural Pain | Assessed immediately following completion of the procedure (as defined as removal of the speculum) | To compare women's maximum procedural pain measured on a visual analog scale (VAS) during a surgical abortion between 12 weeks 0 days to 16 weeks 0 days gestational age between women randomized to nitrous oxide versus intravenous sedation. A score of 0 represents no pain and a score of 100 represents pain as bad as it could be. |
| Satisfaction With Anesthesia (Iowa Satisfaction With Anesthesia Scale [ISAS]) | Assessed 30 minutes after procedure completion. | The Iowa Satisfaction with Anesthesia Scale (ISAS) was given to women following a surgical abortion. The ISAS score is the mean of 11 responses to questions regarding satisfaction with anesthesia and has a score range of -3 (disagree strongly) to 3 (agree strongly). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nitrous Oxide and IV Saline Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.
Nitrous Oxide: Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.
IV Saline | 19 |
| Standard Care Group (IV Sedation and Oxygen) Within the IV sedation group, women will receive 100mcg fentanyl and 2mg midazolam at least two minutes prior to initiation of the procedure. This group will also receive 100% oxygen by a scented face mask. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively. | 20 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | equipment malfunction | 1 | 0 |
Baseline characteristics
| Characteristic | Standard Care Group (IV Sedation and Oxygen) | Total | Nitrous Oxide and IV Saline |
|---|---|---|---|
| Age, Continuous | 26.8 years | 27.1 years | 27.5 years |
| Education Bachelor's or graduate degree | 3 Participants | 6 Participants | 3 Participants |
| Education High school or equivalent | 8 Participants | 16 Participants | 8 Participants |
| Education More than high school | 9 Participants | 17 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 19 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 20 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gestational Age 12 weeks | 8 Participants | 16 Participants | 8 Participants |
| Gestational Age 13 weeks | 4 Participants | 7 Participants | 3 Participants |
| Gestational Age 14 weeks | 5 Participants | 10 Participants | 5 Participants |
| Gestational Age 15 weeks | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Race American Indian/ Alaska Native | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Black or African American | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized Race Other: including bi and mutiracial | 9 Participants | 15 Participants | 6 Participants |
| Race/Ethnicity, Customized Race White | 8 Participants | 16 Participants | 8 Participants |
| Relationship Status In a committed relationship | 13 Participants | 26 Participants | 13 Participants |
| Relationship Status Not in a committed relationship | 7 Participants | 13 Participants | 6 Participants |
| Sex: Female, Male Female | 20 Participants | 39 Participants | 19 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 | 0 / 19 | 0 / 20 |
| other Total, other adverse events | 0 / 19 | 0 / 20 |
| serious Total, serious adverse events | 0 / 19 | 0 / 20 |
Outcome results
Primary
Satisfaction With Anesthesia (Iowa Satisfaction With Anesthesia Scale [ISAS])
The Iowa Satisfaction with Anesthesia Scale (ISAS) was given to women following a surgical abortion. The ISAS score is the mean of 11 responses to questions regarding satisfaction with anesthesia and has a score range of -3 (disagree strongly) to 3 (agree strongly).
Time frame: Assessed 30 minutes after procedure completion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nitrous Oxide and IV Saline | Satisfaction With Anesthesia (Iowa Satisfaction With Anesthesia Scale [ISAS]) | 0.7 units on a scale | Standard Deviation 1 |
| Standard Care Group (IV Sedation and Oxygen) | Satisfaction With Anesthesia (Iowa Satisfaction With Anesthesia Scale [ISAS]) | 1.8 units on a scale | Standard Deviation 1 |
Primary
Visual Analog Scale (VAS) Score for Maximum Procedural Pain
To compare women's maximum procedural pain measured on a visual analog scale (VAS) during a surgical abortion between 12 weeks 0 days to 16 weeks 0 days gestational age between women randomized to nitrous oxide versus intravenous sedation. A score of 0 represents no pain and a score of 100 represents pain as bad as it could be.
Time frame: Assessed immediately following completion of the procedure (as defined as removal of the speculum)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nitrous Oxide and IV Saline | Visual Analog Scale (VAS) Score for Maximum Procedural Pain | 54.1 units on a scale |
| Standard Care Group (IV Sedation and Oxygen) | Visual Analog Scale (VAS) Score for Maximum Procedural Pain | 34.0 units on a scale |