At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Preeclampsia And Nonsteroidal Drugs for Analgesia (PANDA): a Randomized Non Inferiority Trial
In Brief
A Phase 2 clinical trial evaluating Ibuprofen 600 mg, Ketorolac, and 2 other interventions for Preeclampsia Severe and Preeclampsia Postpartum. Completed, enrolled 287 participants across 1 site.
Signals
Detailed Summary
A randomized non-inferiority trial of women with preeclampsia with severe features to determine if the addition of nonsteroidal anti-inflammatory drugs is inferior or non-inferior to standard analgesic bundles in their impact on postpartum hypertension.
Study Details
Timeline
Arms & Interventions
Ibuprofen 600mg PO q 6 hrs as needed for pain, Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain. In patients undergoing cesarean section, ketorolac 30mg IV q 6 hrs may be substituted as an IV alternative to ibuprofen for the first 24 hours after surgery
Acetaminophen 1000mg q 8 hrs as needed for pain, and Oxycodone 5 to 10 mg q 4 hrs as needed for pain.
Interventions
NSAID pain medication to be used in the experimental bundle for postpartum analgesia
NSAID analgesic to be used in the experimental bundle for postpartum analgesia in patients who underwent cesarean section
Analgesic medication to be used in both treatment arms
Analgesic medication to be used in both treatment arms