Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
NCT Number: NCT04067609
Investigating if giving post-operative dexamethasone to patients with a history of opioid use disorder on medication assisted treatment during pregnancy improves their pain scores and decreases their opioid use after cesarean section.
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Female
Interventional
Phase 4
New Haven, Connecticut, 06510, United States
For this study, the researchers are most interested in an option that would be able to be administered consistently (same time/same way): that labor nurses could give and without requiring the patient to have had an epidural placement. Further, Gabapentin, clonidine and ketamine are associated with CNS effects like sedation or confusion that could make health care providers less likely to be comfortable giving these women additional oxycodone due to possible worsened sedation or respiratory depression. Lastly, the researchers wanted to give a drug that both obstetricians and pediatricians were comfortable with from extensive use in our maternal population. Thus, a single administration IV dexamethasone was chosen for this study. Dexamethasone has been used as an adjunct for post-operative pain management in many types of surgeries. Although no large randomized trials exist, several small trials suggest an analgesic and opioid sparing effect of dexamethasone post-operatively for both pregnant and non-pregnanat patients; however these studies excluded patients on MAT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline
100mL of normal saline (placebo)
Time frame: 24, 48, 72 and 96 hours post-op
Pain scores via the standardly used and accepted Visual Analog Scale ranging from 1 (lowest) to 10 (highest).
Time frame: 24, 48 and 72 hours post-op
Comparison of total morphine dose equivalents used by the patient during this period will be examined. The total morphine dose equivalents will be calculated from the total narcotic dose and appropriate conversion (i.e. dilaudid dose to morphine dose equivalents). This will be calculated as a total daily dose for the hospital stay and an average dose/d over the entire hospital stay. These 2 separate calculations will be used because it is presumed that narcotic use will decrease with each day post-op. Calculating an average dose/d over the entire hospital stay will account for women who are discharged on different postoperative days.
Yale University
Other
Postoperative Dexamethasone on Post-Cesarean Pain in Patients Using Medication Assisted Treatment (MAT)
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