Pain, Postoperative, Postoperative Nausea and Vomiting
Conditions
Keywords
Anesthesia, Cesarean Section, Pain, Postoperative, Postoperative Nausea and Vomiting, Dexamethasone, Injections, Spinal, morphine
Brief summary
The purpose of this study is to compare post-cesarean section consumption of pain medication between two groups of patients undergoing scheduled cesarean section at term gestation who receive a single-dose of intraoperative steroid (dexamethasone 8 milligrams) versus placebo at 24 hours after surgery. The hypothesis is that a single perioperative dose of dexamethasone 8 mg will significantly reduce postoperative opioid consumption at 24 h in women having cesarean delivery under spinal anesthesia.
Detailed description
Steroids have been used to reduce inflammation and tissue damage in a variety of conditions, have potent immunomodulatory effects, and are a mainstay in the treatment of acute allograft rejection. Dexamethasone has been shown to be a safe and effective anti-emetic therapy for patients undergoing cesarean section surgery with spinal anesthesia containing morphine. However, recent evidence suggests that dexamethasone may also play a role in reducing post-operative pain and opioid consumption. Early studies in patients undergoing dental procedures showed that glucocorticoids were effective in reducing postoperative pain and edema. Multiple recent studies have also investigated the potential analgesic benefit of a single perioperative dose of dexamethasone, but the results have been inconsistent. The effect of single-dose, intraoperative, intravenous dexamethasone therapy on post-operative pain and opioid consumption has not yet been studied in patients undergoing cesarean section. Pain is a significant source of morbidity for many women following cesarean section, and has serious consequences beyond the immediate post-operative period. Patients with poorly-controlled pain may have difficulty with ambulation that can lead to atelectasis, pneumonia, and venous thromboembolism. Poor maternal pain control may also affect the infant by interfering with bonding and breastfeeding. Reduction of post-operative opioid consumption is desirable because it may also reduce the incidence of opioid-induced side effects such as sedation, constipation, nausea, vomiting and pruritus. Some evidence suggests that the severity of post-operative pain following cesarean section may predict progression to chronic pain, and postpartum depression. Although 10 to 18% of women who undergo cesarean section will experience chronic pain following surgery, it is difficult to predict those patients who will experience this complication. Recent investigations have shown that patient responses to standardized painful stimuli prior to surgery help predict severity of post-operative pain and possibly progression to chronic pain. This type of information could potentially help to tailor the clinical management of patients at risk for severe and/or chronic post-operative pain to improve outcomes for these patients. Landau and colleagues have described a simple and minimally-invasive method of assessing response to noxious stimuli using a von-Frey filament to obtain a mechanical temporal summation score.
Interventions
DRUGDexamethasone
Dexamethasone 8 mg IV (as a one time dose)
DRUGPlacebo
Sodium Chloride 0.9% -5 ml
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiology (ASA) class 1, 2 and 3 * Gestational age \> 37 weeks * scheduled for elective cesarean delivery * spinal or combined spinal epidural anesthesia * 18 years or older * speak English
Exclusion criteria
* BMI \> 45 kg/m2 * Diabetes Mellitus (Type 1, 2 and gestational) * mild or severe preeclampsia * history of intravenous drug or opioid abuse * previous history of chronic pain syndrome * history of opioid use in the past week * receipt of an antiemetic within 24 h prior to surgery * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morphine Consumption at 24 Hours Post-op | 24 hours from admission to Postanesthesia care unit (PACU) | The primary outcome will be the cumulative morphine consumption at 24 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Administration of First Rescue Analgesic Request Between the Groups. | PACU admission to discharge from PACU an average of 2 hours | Time in minutes from admission to PACU to the first request by the patient for oral oxycodone (analgesia) administration for pain |
| Cumulative Opioid Consumption at 48 Hours Between the Groups | Admission to PACU through 48 hours | The secondary outcome was the cumulative morphine consumption at 48 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine |
| Pain Scores Between the Groups at 24 Hours. | 24 hours from PACU admission | Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain. |
| Pain Scores Between the Groups at 48 Hours. | 48 hours from PACU Admission | Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain. |
| Cumulative Opioid Consumption at 24 Hours Between MTS Groups | 24 hours from admission to Postanesthesia care unit (PACU) | Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0 = no pain and 100= worst pain possible) after the 1st and 11th tap. A difference \< 1 was recorded as MTS negative, and a difference \> or = 1 was recorded as MTS positive. |
| Incidence of Chronic Persistent Pain at 8 Weeks | 8 weeks from the day of surgery | Patients answered a questionnaire at 8 weeks to determine whether they still had persistent surgical site pain 8 weeks following surgery |
| Incidence of Chronic Persistent Pain at 6 Months | 6 months from the day of surgery | Patients answered a questionnaire at 6 months to determine whether they still had persistent surgical site pain 6 months following surgery |
| Pain Scores Between the Groups at 2 Hours. | 2 hours from admission to postanesthesia care unit (PACU) | Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain. |
| Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics. | From spinal anesthesia placement to end of surgery, approximately 70 minutes | Incidence of intraoperative nausea and vomiting and need for rescue antiemetics were recorded during surgery. Patient who reported a nausea score on a 11 point NRS where 0=no nausea and 10 = the worse nausea possible. Patients who retched or vomited were reported to have vomited. Patients receiving any antiemetic during surgery were recorded as those requesting ( needing) rescue antiemetic. |
| Incidence of Intraoperative Pruritus | From spinal anesthesia placement to end of surgery, approximately 70 minutes | pruritus was defined as patients reporting a pruritus score of greater than o on a numerical rating scale with o=no pruritus and 10= worst pruritus |
| Incidence of Postoperative Pruritus | 48 hours from admission to PACU | Incidence of postoperative pruritus was calculated based on their postoperative pruritus scores measured at 2 hours, 24 hours and 48 hours. Median of the scores recorded at three time points was calculated. If median score \>0 then patient experienced postoperative pruritus. |
| Need for Intraoperative Analgesic Supplementation | From spinal anesthesia placement to end of surgery, approximately 70 minutes | Need for intraoperative analgesic supplementation was determined by patients who required intraoperative analgesics for pain |
| Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics | 2, 24 and 48 hours from PACU admission | Patients who had experienced Postoperative nausea either reported postoperative nausea scores at 2, 24 and 48 hours from \>0, reported an episode of vomiting or received an antiemetic were recorded as experiencing PONV. Patients who received at least one rescue antiemetic postoperatively were recorded as requiring a rescue antiemetic |
| Incidence of Wound Complications | 24 hours from PACU admission | Patients were assessed for signs of surgical wound inspection by the obstetric team following surgery |
| Blood Pressure Measurements Obtained by the Standard of Care Non-invasive Blood Pressure Monitor Compared With the Continuous Noninvasive Arterial Pressure (CNAP) | Intraoperatively | — |
| Pain Scores Between MTS Groups | 24 hours after PACU admission | Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0=no pain and 100=worst pain possible) after the 1st and 11th tap. A difference \< 1 was recorded as MTS negative, and a difference \> or = 1 was recorded as MTS positive. |
Countries
United States
Participant flow
Pre-assignment details
Of the 52 subjects that were enrolled, 3 subjects were not randomized due to later being deemed ineligible for the study; therefore, 49 subjects started on study.
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone Dexamethasone 8 mg IV given intraoperatively as a one-time dose.
Dexamethasone: Dexamethasone 8 mg IV (as a one time dose) | 23 |
| Placebo Sodium chloride 0.9% (5 ml) given IV intraoperatively as a one time dose.
Placebo: Sodium Chloride 0.9% -5 ml | 24 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Dexamethasone | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 32.2 years STANDARD_DEVIATION 4.7 | 30.63 years STANDARD_DEVIATION 5.71 | 31.40 years STANDARD_DEVIATION 5.23 |
| Race/Ethnicity, Customized Race/Ethnicity Asian/Indian | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black/African American | 6 Participants | 5 Participants | 11 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Caucasian | 17 Participants | 14 Participants | 31 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 23 participants | 24 participants | 47 participants |
| Sex: Female, Male Female | 23 Participants | 24 Participants | 47 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 / 23 | 0 / 24 |
| serious Total, serious adverse events | 0 / 23 | 0 / 24 |
Outcome results
Primary
Morphine Consumption at 24 Hours Post-op
The primary outcome will be the cumulative morphine consumption at 24 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine
Time frame: 24 hours from admission to Postanesthesia care unit (PACU)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexamethasone | Morphine Consumption at 24 Hours Post-op | 15 milligram |
| Placebo | Morphine Consumption at 24 Hours Post-op | 13.75 milligram |
p-value: 0.74Wilcoxon (Mann-Whitney)
Secondary
Blood Pressure Measurements Obtained by the Standard of Care Non-invasive Blood Pressure Monitor Compared With the Continuous Noninvasive Arterial Pressure (CNAP)
Time frame: Intraoperatively
Population: No data was collected intraoperatively using CNAP on any participants.
Secondary
Cumulative Opioid Consumption at 24 Hours Between MTS Groups
Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0 = no pain and 100= worst pain possible) after the 1st and 11th tap. A difference \< 1 was recorded as MTS negative, and a difference \> or = 1 was recorded as MTS positive.
Time frame: 24 hours from admission to Postanesthesia care unit (PACU)
Population: Analysis was based on all 47 patients who completed the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexamethasone | Cumulative Opioid Consumption at 24 Hours Between MTS Groups | 17.5 milligrams |
| Placebo | Cumulative Opioid Consumption at 24 Hours Between MTS Groups | 15 milligrams |
p-value: 0.355Wilcoxon (Mann-Whitney)
Secondary
Cumulative Opioid Consumption at 48 Hours Between the Groups
The secondary outcome was the cumulative morphine consumption at 48 h in the two study groups. All postoperative opioids were converted to IV morphine equivalents using the following conversion factors: 100 micrograms IV = 10 mg IV morphine, 20 mg oxycodone po = 10 mg IV Morphine
Time frame: Admission to PACU through 48 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexamethasone | Cumulative Opioid Consumption at 48 Hours Between the Groups | 20 milligrams |
| Placebo | Cumulative Opioid Consumption at 48 Hours Between the Groups | 22.5 milligrams |
p-value: 0.709Wilcoxon (Mann-Whitney)
Secondary
Incidence of Chronic Persistent Pain at 6 Months
Patients answered a questionnaire at 6 months to determine whether they still had persistent surgical site pain 6 months following surgery
Time frame: 6 months from the day of surgery
Population: Analysis was based on available data from both arms including 25 patients. Data was missing for 11 patients in dexamethasone group and 11 patients in placebo group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone | Incidence of Chronic Persistent Pain at 6 Months | 3 Participants |
| Placebo | Incidence of Chronic Persistent Pain at 6 Months | 1 Participants |
p-value: 0.322Fisher Exact
Secondary
Incidence of Chronic Persistent Pain at 8 Weeks
Patients answered a questionnaire at 8 weeks to determine whether they still had persistent surgical site pain 8 weeks following surgery
Time frame: 8 weeks from the day of surgery
Population: Analysis was based on available data from both arms including 26 patients. Data was missing for 13 patients in dexamethasone group and 8 patients in placebo group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone | Incidence of Chronic Persistent Pain at 8 Weeks | 2 Participants |
| Placebo | Incidence of Chronic Persistent Pain at 8 Weeks | 6 Participants |
p-value: 0.42Fisher Exact
Secondary
Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics.
Incidence of intraoperative nausea and vomiting and need for rescue antiemetics were recorded during surgery. Patient who reported a nausea score on a 11 point NRS where 0=no nausea and 10 = the worse nausea possible. Patients who retched or vomited were reported to have vomited. Patients receiving any antiemetic during surgery were recorded as those requesting ( needing) rescue antiemetic.
Time frame: From spinal anesthesia placement to end of surgery, approximately 70 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone | Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics. | Intraoperative need for rescue antiemetic | 10 Participants |
| Dexamethasone | Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics. | Incidence of intraoperative nausea | 5 Participants |
| Dexamethasone | Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics. | Incidence of intraoperative vomiting | 4 Participants |
| Placebo | Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics. | Intraoperative need for rescue antiemetic | 9 Participants |
| Placebo | Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics. | Incidence of intraoperative nausea | 2 Participants |
| Placebo | Incidence of Intraoperative Nausea and Vomiting (IONV) and Need for Rescue Antiemetics. | Incidence of intraoperative vomiting | 5 Participants |
p-value: 0.245Fisher Exact
p-value: 0.676Chi-squared
p-value: 1Fisher Exact
Secondary
Incidence of Intraoperative Pruritus
pruritus was defined as patients reporting a pruritus score of greater than o on a numerical rating scale with o=no pruritus and 10= worst pruritus
Time frame: From spinal anesthesia placement to end of surgery, approximately 70 minutes
Population: No data was collected on intraoperative pruritus on any participants.
Secondary
Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics
Patients who had experienced Postoperative nausea either reported postoperative nausea scores at 2, 24 and 48 hours from \>0, reported an episode of vomiting or received an antiemetic were recorded as experiencing PONV. Patients who received at least one rescue antiemetic postoperatively were recorded as requiring a rescue antiemetic
Time frame: 2, 24 and 48 hours from PACU admission
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone | Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics | Postoperative need for rescue antiemetics | 10 Participants |
| Dexamethasone | Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics | Incidence of PONV at 24 hours | 9 Participants |
| Dexamethasone | Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics | Incidence of PONV at 48 hours | 1 Participants |
| Dexamethasone | Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics | Incidence of PONV at 2 h | 9 Participants |
| Placebo | Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics | Incidence of PONV at 2 h | 14 Participants |
| Placebo | Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics | Postoperative need for rescue antiemetics | 18 Participants |
| Placebo | Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics | Incidence of PONV at 48 hours | 2 Participants |
| Placebo | Incidence of Post-operative Nausea and Vomiting (PONV) and Need for Rescue Antiemetics | Incidence of PONV at 24 hours | 13 Participants |
p-value: 0.302Chi-squared
p-value: 0.028Chi-squared
p-value: 1Fisher Exact
p-value: 0.188Chi-squared
Secondary
Incidence of Postoperative Pruritus
Incidence of postoperative pruritus was calculated based on their postoperative pruritus scores measured at 2 hours, 24 hours and 48 hours. Median of the scores recorded at three time points was calculated. If median score \>0 then patient experienced postoperative pruritus.
Time frame: 48 hours from admission to PACU
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone | Incidence of Postoperative Pruritus | 16 Participants |
| Placebo | Incidence of Postoperative Pruritus | 17 Participants |
p-value: 0.924Chi-squared
Secondary
Incidence of Wound Complications
Patients were assessed for signs of surgical wound inspection by the obstetric team following surgery
Time frame: 24 hours from PACU admission
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone | Incidence of Wound Complications | 0 Participants |
| Placebo | Incidence of Wound Complications | 0 Participants |
Secondary
Need for Intraoperative Analgesic Supplementation
Need for intraoperative analgesic supplementation was determined by patients who required intraoperative analgesics for pain
Time frame: From spinal anesthesia placement to end of surgery, approximately 70 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexamethasone | Need for Intraoperative Analgesic Supplementation | 4 Participants |
| Placebo | Need for Intraoperative Analgesic Supplementation | 3 Participants |
p-value: 0.7Fisher Exact
Secondary
Pain Scores Between MTS Groups
Mechanical temporal summation (MTS) was assessed using A 180 g Von Frey Filament was applied to the volar aspect of the dominant forearm, and subjects were asked to rate pain scores (NRS 0-100, 0=no pain and 100=worst pain possible) after the 1st and 11th tap. A difference \< 1 was recorded as MTS negative, and a difference \> or = 1 was recorded as MTS positive.
Time frame: 24 hours after PACU admission
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dexamethasone | Pain Scores Between MTS Groups | Pain scores at rest at 24 hours | 2.0 units on a scale |
| Dexamethasone | Pain Scores Between MTS Groups | Pains scores on movement at 24 hours | 5.0 units on a scale |
| Placebo | Pain Scores Between MTS Groups | Pain scores at rest at 24 hours | 2.0 units on a scale |
| Placebo | Pain Scores Between MTS Groups | Pains scores on movement at 24 hours | 4.0 units on a scale |
Comparison: 24 hour pain scores at rest between MTS groupsp-value: 0.805Wilcoxon (Mann-Whitney)
Comparison: Pain scores on movement at 24hp-value: 1Wilcoxon (Mann-Whitney)
Secondary
Pain Scores Between the Groups at 24 Hours.
Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.
Time frame: 24 hours from PACU admission
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dexamethasone | Pain Scores Between the Groups at 24 Hours. | Pain Score at rest | 2 units on a scale |
| Dexamethasone | Pain Scores Between the Groups at 24 Hours. | Pain Score with movement | 5 units on a scale |
| Placebo | Pain Scores Between the Groups at 24 Hours. | Pain Score with movement | 5 units on a scale |
| Placebo | Pain Scores Between the Groups at 24 Hours. | Pain Score at rest | 2.5 units on a scale |
p-value: 0.267Wilcoxon (Mann-Whitney)
p-value: 0.518t-test, 2 sided
Secondary
Pain Scores Between the Groups at 2 Hours.
Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.
Time frame: 2 hours from admission to postanesthesia care unit (PACU)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Dexamethasone | Pain Scores Between the Groups at 2 Hours. | Pain Score at rest | 2 units on a scale |
| Dexamethasone | Pain Scores Between the Groups at 2 Hours. | Pain Score with movement | 5 units on a scale |
| Placebo | Pain Scores Between the Groups at 2 Hours. | Pain Score at rest | 3.5 units on a scale |
| Placebo | Pain Scores Between the Groups at 2 Hours. | Pain Score with movement | 5 units on a scale |
p-value: 0.171t-test, 2 sided
p-value: 0.204t-test, 2 sided
Secondary
Pain Scores Between the Groups at 48 Hours.
Pain scores were measured using a numeric rating scale with a range from 0 to 10, with 0 meaning no pain and 10 indicating the most severe pain.
Time frame: 48 hours from PACU Admission
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Dexamethasone | Pain Scores Between the Groups at 48 Hours. | Pain Score at rest | 2.0 units on a scale |
| Dexamethasone | Pain Scores Between the Groups at 48 Hours. | Pain Score with movement | 4.0 units on a scale |
| Placebo | Pain Scores Between the Groups at 48 Hours. | Pain Score at rest | 2.0 units on a scale |
| Placebo | Pain Scores Between the Groups at 48 Hours. | Pain Score with movement | 5.0 units on a scale |
p-value: 0.491Wilcoxon (Mann-Whitney)
p-value: 0.525Wilcoxon (Mann-Whitney)
Secondary
Time to Administration of First Rescue Analgesic Request Between the Groups.
Time in minutes from admission to PACU to the first request by the patient for oral oxycodone (analgesia) administration for pain
Time frame: PACU admission to discharge from PACU an average of 2 hours
Population: Analysis was based on all 47 patients who completed the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexamethasone | Time to Administration of First Rescue Analgesic Request Between the Groups. | 52.5 minutes |
| Placebo | Time to Administration of First Rescue Analgesic Request Between the Groups. | 70 minutes |
p-value: 0.1965Log Rank