Pain
Conditions
Keywords
Perioperative pain, Outpatient surgery, Obstetrics/gynecology, Pain management
Brief summary
This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2 hours preoperatively in conjunction with perioperative paracervical block for surgical abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with surgical abortion. Additionally, the researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and consumption of pain medication.
Detailed description
Project Summary Justification for the project One half of all pregnancies among American women are unintended, with nearly 4 in 10 ending in pregnancy termination by abortion. Elective abortions are among the most common outpatient surgical procedure, with an estimated 46 million performed worldwide annually. The management of pain is critical to patient care throughout the abortion experience since the vast majority of women will experience pain with the procedure. Patients are most affected by pain during paracervical block, cervical dilation, suction aspiration, and post operatively with uterine cramping. Innovation in pain control and reduction of anxiety, nausea and vomiting using a low cost, well-tolerated intervention could impact thousands of women each year. Proposed research This is a randomized controlled trial of gabapentin 600 mg compared to placebo given 1-2 hours preoperatively in conjunction with perioperative paracervical block for surgical abortion. The researchers hypothesize that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with surgical abortion. Additionally, the researchers hypothesize that gabapentin will reduce nausea, vomiting, anxiety, and consumption of pain medication. New features Gabapentin as an adjunct o pain management has proven beneficial in gynecological surgery. Its use in similar surgical settings as an adjunct to pain management regiments has proven to be beneficial. It is generally well tolerated, inexpensive, has minimal side effects, and few contraindications. Problems anticipated The high volume at the study clinic will benefit recruitment efforts, however, as the coordination of this study may potentially disrupt clinic flow there will be limits on daily recruitment. Postoperative follow-up may be challenging, thus to reduce the impact of loss to follow-up, most of the outcomes are measured on the same day as the procedure. Further, multiple contact approaches will be employed and a second incentive offered after completion of the postoperative assessment.
Interventions
DRUGGabapentin
Participants in this group will receive 600 mg of gabapentin given 1-2 hours pre-operatively in conjunction with perioperative paracervical block for surgical abortion. Gabapentin is an FDA approved medication that is used to prevent seizures and to treat various forms of chronic and acute pain.
DRUGPlacebo
Participants in this group will receive 600 mg of gelatin capsules that are identical in appearance to gabapentin capsules. The placebo will be given 1-2 hours pre-operatively in conjunction with perioperative paracervical block for surgical abortion.
Sponsors
Society of Family Planning
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women \>=18 years-old * Presenting for a surgical abortion * Fluency in English and able to provide informed consent * Has a driver to take them home following the procedure
Exclusion criteria
* Allergy, sensitivity or contraindication to gabapentin * Severe renal disease * Currently using gabapentin or pregabalin * Contraindication to outpatient abortion under local anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain at Time of Uterine Evacuation | During the procedure on Study Day 1 | The primary outcome measure is a pain score using a 100-mm visual analog scale (VAS) measured intraoperatively at time of evacuation. No pain is scored as 0 and worst pain imaginable is scored as 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Using Pain Medication | Postoperative Day 1 | The number of participants reporting filling and using the prescription for ibuprofen postoperatively. During the follow-up phone call on the day after the procedure, participants were asked whether or not they filled the pain medication prescription and if they took any of the medication. |
| Perioperative Nausea | Pre-procedure through post-procedure on Study Day 1 | Nausea level was measured using a 100-mm visual analog scale (VAS) to log the change in nausea levels between the study arms. No nausea is reported as 0 while worst nausea I have ever felt is reported at 100. Nausea was reported immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure. |
| Perioperative Vomiting | Pre-procedure through post-procedure on Study Day 1 | Participants reported if they vomited during the perioperative period to assess changes in vomiting incidences between the study arms. Vomiting is reported for the time periods of immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure. |
| Anxiety Levels | Pre-procedure through post-procedure on Study Day 1 | Participants reported how much anxiety they were currently experiencing on a 100-point scale where No Anxiety is scored as 0 and Extremely Anxious is scored as 100. Anxiety is reported for the time periods of immediately prior to the procedure, 10 minutes after the procedure, and 30 minutes after the procedure. |
| Side Effects | 10 and 30 minutes post procedure on Study Day 1 | Participants were asked if they experienced dizziness, lack of muscle control, sleepiness or drowsiness, weakness or lack of energy, headache, or visual changes. |
| Perioperative Pain Level | Pre-procedure through post-procedure on Study Day 1 | Pain level at a variety of time points will be measured using a 100-mm visual analog scale (VAS) to log the change in pain levels between the study arms. No pain is scored as 0 and worst pain imaginable is scored as 100. Pain will be assessed immediately prior to the procedure, at completion of the procedure (removal of the speculum), 10 minutes following the procedure, and 30 minutes following the procedure (at discharge). |
| Severe Pain at Postoperation Follow-up Assessment | Postoperative Day 1 | During the Postoperative Day 1 phone call, participants self reported how much they experienced severe pain in the last 24 hours where 10 = none of the time and 0 = all of the time. Severe pain was defined according to the perception of each participant. |
| Nausea or Vomiting at Postoperation Follow-up Assessment | Postoperative Day 1 | During the Postoperative Day 1 phone call, participants self reported how much they experienced nausea or vomiting in the last 24 hours where 10 = none of the time and 0 = all of the time. Nausea and vomiting were self-reported together as a single outcome. |
| Vomiting Since Leaving Clinic | Postoperative Day 1 | During the Postoperative Day 1 phone call, participants self reported whether or not they had vomited since leaving the clinic. |
| Overall Satisfaction With the Procedure | Postoperative Day 1 | Overall satisfaction with the procedure was assessed on a 10-point scale on the day after the procedure, where 1 = very dissatisfied and 10 = very satisfied. |
| Moderate Pain at Postoperation Follow-up Assessment | Postoperative Day 1 | During the Postoperative Day 1 phone call, participants self reported how much they experienced moderate pain in the last 24 hours where 10 = none of the time and 0 = all of the time. Moderate pain was defined according to the perception of each participant. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the Atlanta Women's Center in Atlanta, Georgia. Enrollment began on December 8, 2016 and all study procedures concluded on June 26, 2018.
Pre-assignment details
A total of 122 individuals were eligible and consented to participate in the study. Six withdrew prior to randomization and an additional 2 withdrew prior to beginning the study, resulting in 114 receiving the intervention.
Participants by arm
| Arm | Count |
|---|---|
| Gabapentin Group Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure. | 54 |
| Placebo Group Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of a placebo to match gabapentin 1-2 hours prior to the procedure. | 57 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 7 | 10 |
| Overall Study | No longer eligible | 3 | 0 |
Baseline characteristics
| Characteristic | Total | Placebo Group | Gabapentin Group |
|---|---|---|---|
| Age, Continuous | 26.01 years STANDARD_DEVIATION 5.52 | 26.8 years STANDARD_DEVIATION 5.5 | 25.2 years STANDARD_DEVIATION 5.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 106 Participants | 55 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gestational age | 61.3 days STANDARD_DEVIATION 14.1 | 62.5 days STANDARD_DEVIATION 13.2 | 60.1 days STANDARD_DEVIATION 15.1 |
| Race/Ethnicity, Customized American Indian | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black/African American | 76 Participants | 41 Participants | 35 Participants |
| Race/Ethnicity, Customized Don't know/Refused/Not Specified | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Mixed or multi-racial | 4 Participants | 4 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White/Caucasian | 27 Participants | 12 Participants | 15 Participants |
| Region of Enrollment United States | 111 participants | 57 participants | 54 participants |
| Sex: Female, Male Female | 111 Participants | 57 Participants | 54 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 / 54 | 0 / 57 |
| other Total, other adverse events | 1 / 54 | 1 / 57 |
| serious Total, serious adverse events | 0 / 54 | 0 / 57 |
Outcome results
Primary
Pain at Time of Uterine Evacuation
The primary outcome measure is a pain score using a 100-mm visual analog scale (VAS) measured intraoperatively at time of evacuation. No pain is scored as 0 and worst pain imaginable is scored as 100.
Time frame: During the procedure on Study Day 1
Population: Participants completing all assessments on the day of the procedure are included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gabapentin Group | Pain at Time of Uterine Evacuation | Paracervical block | 63.79 score on a scale | Standard Error 3.77 |
| Gabapentin Group | Pain at Time of Uterine Evacuation | Dilation | 64.58 score on a scale | Standard Error 3.74 |
| Gabapentin Group | Pain at Time of Uterine Evacuation | Aspiration | 67.77 score on a scale | Standard Error 3.63 |
| Placebo Group | Pain at Time of Uterine Evacuation | Paracervical block | 62.21 score on a scale | Standard Error 3.52 |
| Placebo Group | Pain at Time of Uterine Evacuation | Dilation | 66.12 score on a scale | Standard Error 3.54 |
| Placebo Group | Pain at Time of Uterine Evacuation | Aspiration | 71.06 score on a scale | Standard Error 3.49 |
Secondary
Anxiety Levels
Participants reported how much anxiety they were currently experiencing on a 100-point scale where No Anxiety is scored as 0 and Extremely Anxious is scored as 100. Anxiety is reported for the time periods of immediately prior to the procedure, 10 minutes after the procedure, and 30 minutes after the procedure.
Time frame: Pre-procedure through post-procedure on Study Day 1
Population: Participants completing all assessments on the day of the procedure are included in this analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gabapentin Group | Anxiety Levels | Prior to procedure | 66 score on a scale |
| Gabapentin Group | Anxiety Levels | 10 minutes post-procedure | 14 score on a scale |
| Gabapentin Group | Anxiety Levels | 30 minutes post-procedure | 4 score on a scale |
| Placebo Group | Anxiety Levels | Prior to procedure | 72 score on a scale |
| Placebo Group | Anxiety Levels | 10 minutes post-procedure | 17 score on a scale |
| Placebo Group | Anxiety Levels | 30 minutes post-procedure | 2 score on a scale |
Secondary
Moderate Pain at Postoperation Follow-up Assessment
During the Postoperative Day 1 phone call, participants self reported how much they experienced moderate pain in the last 24 hours where 10 = none of the time and 0 = all of the time. Moderate pain was defined according to the perception of each participant.
Time frame: Postoperative Day 1
Population: Participants completing the follow up assessment one day after the procedure are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin Group | Moderate Pain at Postoperation Follow-up Assessment | 5.2 units on a scale | Standard Deviation 3.5 |
| Placebo Group | Moderate Pain at Postoperation Follow-up Assessment | 5.2 units on a scale | Standard Deviation 3.4 |
Secondary
Nausea or Vomiting at Postoperation Follow-up Assessment
During the Postoperative Day 1 phone call, participants self reported how much they experienced nausea or vomiting in the last 24 hours where 10 = none of the time and 0 = all of the time. Nausea and vomiting were self-reported together as a single outcome.
Time frame: Postoperative Day 1
Population: Participants completing the follow up assessment one day after the procedure are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin Group | Nausea or Vomiting at Postoperation Follow-up Assessment | 2.3 units on a scale | Standard Deviation 3.9 |
| Placebo Group | Nausea or Vomiting at Postoperation Follow-up Assessment | 3.2 units on a scale | Standard Deviation 4.1 |
Secondary
Number of Participants Using Pain Medication
The number of participants reporting filling and using the prescription for ibuprofen postoperatively. During the follow-up phone call on the day after the procedure, participants were asked whether or not they filled the pain medication prescription and if they took any of the medication.
Time frame: Postoperative Day 1
Population: Participants completing the follow up assessment one day after the procedure are included in this analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Gabapentin Group | Number of Participants Using Pain Medication | 24 Participants |
| Placebo Group | Number of Participants Using Pain Medication | 27 Participants |
Secondary
Overall Satisfaction With the Procedure
Overall satisfaction with the procedure was assessed on a 10-point scale on the day after the procedure, where 1 = very dissatisfied and 10 = very satisfied.
Time frame: Postoperative Day 1
Population: Participants completing the follow up assessment one day after the procedure are included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gabapentin Group | Overall Satisfaction With the Procedure | 3 | 0 Participants |
| Gabapentin Group | Overall Satisfaction With the Procedure | 4 | 0 Participants |
| Gabapentin Group | Overall Satisfaction With the Procedure | 5 | 5 Participants |
| Gabapentin Group | Overall Satisfaction With the Procedure | 6 | 0 Participants |
| Gabapentin Group | Overall Satisfaction With the Procedure | 7 | 4 Participants |
| Gabapentin Group | Overall Satisfaction With the Procedure | 8 | 15 Participants |
| Gabapentin Group | Overall Satisfaction With the Procedure | 9 | 5 Participants |
| Gabapentin Group | Overall Satisfaction With the Procedure | 1 (very dissatisfied) | 0 Participants |
| Gabapentin Group | Overall Satisfaction With the Procedure | 2 | 0 Participants |
| Gabapentin Group | Overall Satisfaction With the Procedure | 10 (very satisfied) | 18 Participants |
| Placebo Group | Overall Satisfaction With the Procedure | 10 (very satisfied) | 17 Participants |
| Placebo Group | Overall Satisfaction With the Procedure | 3 | 2 Participants |
| Placebo Group | Overall Satisfaction With the Procedure | 8 | 7 Participants |
| Placebo Group | Overall Satisfaction With the Procedure | 4 | 2 Participants |
| Placebo Group | Overall Satisfaction With the Procedure | 2 | 0 Participants |
| Placebo Group | Overall Satisfaction With the Procedure | 5 | 4 Participants |
| Placebo Group | Overall Satisfaction With the Procedure | 9 | 11 Participants |
| Placebo Group | Overall Satisfaction With the Procedure | 6 | 1 Participants |
| Placebo Group | Overall Satisfaction With the Procedure | 1 (very dissatisfied) | 1 Participants |
| Placebo Group | Overall Satisfaction With the Procedure | 7 | 2 Participants |
Secondary
Perioperative Nausea
Nausea level was measured using a 100-mm visual analog scale (VAS) to log the change in nausea levels between the study arms. No nausea is reported as 0 while worst nausea I have ever felt is reported at 100. Nausea was reported immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure.
Time frame: Pre-procedure through post-procedure on Study Day 1
Population: Participants completing all assessments on the day of the procedure are included in this analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Gabapentin Group | Perioperative Nausea | 10 minutes post-procedure | 1 score on a scale |
| Gabapentin Group | Perioperative Nausea | 30 minutes post-procedure | 0 score on a scale |
| Gabapentin Group | Perioperative Nausea | Prior to procedure | 26 score on a scale |
| Placebo Group | Perioperative Nausea | Prior to procedure | 26 score on a scale |
| Placebo Group | Perioperative Nausea | 10 minutes post-procedure | 12 score on a scale |
| Placebo Group | Perioperative Nausea | 30 minutes post-procedure | 5 score on a scale |
Secondary
Perioperative Pain Level
Pain level at a variety of time points will be measured using a 100-mm visual analog scale (VAS) to log the change in pain levels between the study arms. No pain is scored as 0 and worst pain imaginable is scored as 100. Pain will be assessed immediately prior to the procedure, at completion of the procedure (removal of the speculum), 10 minutes following the procedure, and 30 minutes following the procedure (at discharge).
Time frame: Pre-procedure through post-procedure on Study Day 1
Population: Participants completing all assessments on the day of the procedure are included in this analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Gabapentin Group | Perioperative Pain Level | Prior to procedure | 20.76 score on a scale | Standard Error 3.6 |
| Gabapentin Group | Perioperative Pain Level | Speculum removal | 44.10 score on a scale | Standard Error 3.6 |
| Gabapentin Group | Perioperative Pain Level | 10 minutes post-procedure | 30.64 score on a scale | Standard Error 3.65 |
| Gabapentin Group | Perioperative Pain Level | 30 minutes post-procedure | 20.89 score on a scale | Standard Error 3.68 |
| Placebo Group | Perioperative Pain Level | 30 minutes post-procedure | 31.65 score on a scale | Standard Error 3.54 |
| Placebo Group | Perioperative Pain Level | Prior to procedure | 22.48 score on a scale | Standard Error 3.49 |
| Placebo Group | Perioperative Pain Level | 10 minutes post-procedure | 43.68 score on a scale | Standard Error 3.47 |
| Placebo Group | Perioperative Pain Level | Speculum removal | 47.61 score on a scale | Standard Error 3.52 |
Secondary
Perioperative Vomiting
Participants reported if they vomited during the perioperative period to assess changes in vomiting incidences between the study arms. Vomiting is reported for the time periods of immediately prior to the procedure, 10 minutes following the procedure, and 30 minutes following the procedure.
Time frame: Pre-procedure through post-procedure on Study Day 1
Population: Participants completing all assessments on the day of the procedure are included in this analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gabapentin Group | Perioperative Vomiting | Prior to procedure | 4 Participants |
| Gabapentin Group | Perioperative Vomiting | 10 minutes post-procedure | 5 Participants |
| Gabapentin Group | Perioperative Vomiting | 30 minutes post-procedure | 5 Participants |
| Placebo Group | Perioperative Vomiting | Prior to procedure | 7 Participants |
| Placebo Group | Perioperative Vomiting | 10 minutes post-procedure | 2 Participants |
| Placebo Group | Perioperative Vomiting | 30 minutes post-procedure | 5 Participants |
Secondary
Severe Pain at Postoperation Follow-up Assessment
During the Postoperative Day 1 phone call, participants self reported how much they experienced severe pain in the last 24 hours where 10 = none of the time and 0 = all of the time. Severe pain was defined according to the perception of each participant.
Time frame: Postoperative Day 1
Population: Participants completing the follow up assessment one day after the procedure are included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin Group | Severe Pain at Postoperation Follow-up Assessment | 3.5 units on a scale | Standard Deviation 4.1 |
| Placebo Group | Severe Pain at Postoperation Follow-up Assessment | 3.2 units on a scale | Standard Deviation 4.1 |
Secondary
Side Effects
Participants were asked if they experienced dizziness, lack of muscle control, sleepiness or drowsiness, weakness or lack of energy, headache, or visual changes.
Time frame: 10 and 30 minutes post procedure on Study Day 1
Population: This analysis includes participants responding to the side effects questions. Two did not answer any questions. Two participants in the gabapentin group did not complete the side effect assessment at 30 minutes post-procedure. One participant in the placebo group did not respond to the assessment of weakness at 30 minutes post-procedure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gabapentin Group | Side Effects | Lack of muscle control 30 minutes post-procedure | 5 Participants |
| Gabapentin Group | Side Effects | Headache 10 minutes post-procedure | 5 Participants |
| Gabapentin Group | Side Effects | Sleepiness/drowsiness 30 minutes post-procedure | 30 Participants |
| Gabapentin Group | Side Effects | Headache 30 minutes post-procedure | 4 Participants |
| Gabapentin Group | Side Effects | Lack of muscle control 10 minutes post-procedure | 9 Participants |
| Gabapentin Group | Side Effects | Vision changes 10 minutes post-procedure | 9 Participants |
| Gabapentin Group | Side Effects | Weakness 10 minutes post-procedure | 33 Participants |
| Gabapentin Group | Side Effects | Vision changes 30 minutes post-procedure | 3 Participants |
| Gabapentin Group | Side Effects | Sleepiness/drowsiness 10 minutes post-procedure | 38 Participants |
| Gabapentin Group | Side Effects | Dizziness 10 minutes post-procedure | 27 Participants |
| Gabapentin Group | Side Effects | Weakness 30 minutes post-procedure | 20 Participants |
| Gabapentin Group | Side Effects | Dizziness 30 minutes post-procedure | 19 Participants |
| Placebo Group | Side Effects | Weakness 30 minutes post-procedure | 28 Participants |
| Placebo Group | Side Effects | Lack of muscle control 10 minutes post-procedure | 9 Participants |
| Placebo Group | Side Effects | Lack of muscle control 30 minutes post-procedure | 10 Participants |
| Placebo Group | Side Effects | Sleepiness/drowsiness 10 minutes post-procedure | 34 Participants |
| Placebo Group | Side Effects | Sleepiness/drowsiness 30 minutes post-procedure | 29 Participants |
| Placebo Group | Side Effects | Weakness 10 minutes post-procedure | 34 Participants |
| Placebo Group | Side Effects | Dizziness 30 minutes post-procedure | 15 Participants |
| Placebo Group | Side Effects | Headache 10 minutes post-procedure | 4 Participants |
| Placebo Group | Side Effects | Headache 30 minutes post-procedure | 4 Participants |
| Placebo Group | Side Effects | Vision changes 10 minutes post-procedure | 11 Participants |
| Placebo Group | Side Effects | Vision changes 30 minutes post-procedure | 5 Participants |
| Placebo Group | Side Effects | Dizziness 10 minutes post-procedure | 23 Participants |
Secondary
Vomiting Since Leaving Clinic
During the Postoperative Day 1 phone call, participants self reported whether or not they had vomited since leaving the clinic.
Time frame: Postoperative Day 1
Population: Participants completing the follow up assessment one day after the procedure are included in this analysis.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gabapentin Group | Vomiting Since Leaving Clinic | No vomiting | 46 Participants |
| Gabapentin Group | Vomiting Since Leaving Clinic | Vomiting at least once | 1 Participants |
| Placebo Group | Vomiting Since Leaving Clinic | No vomiting | 45 Participants |
| Placebo Group | Vomiting Since Leaving Clinic | Vomiting at least once | 2 Participants |