NCT03978767

Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial

Preeclampsia And Nonsteroidal Drugs for Analgesia (PANDA): a Randomized Non Inferiority Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 287 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

Recently published clinical guidelines for the care of women with hypertensive disorders recommended that nonsteroidal anti-inflammatory drugs (NSAIDs) should be withheld from patients with hypertension that persists for more than one day postpartum (1). This recommendation is based in data from the general medicine literature, which suggests a role of NSAIDs in precipitating hypertension in non-pregnant adults (2,3). It may also draw from previously published case reports of post-partum hypertension that were thought to be NSAID induced (4). There has been a paucity of data from the obstetric literature to support or rebuff this recommendation. As the opioid crisis worsens in the United States, additional attention and resources have focused on limiting the use of narcotic medications. The effective employment of non-opioid analgesics has been shown to reduce narcotic use (5). Ibuprofen and other NSAIDs are the most effective and most commonly prescribed analgesics for postpartum pain, but clinicians now find themselves stuck between these recommendations and their efforts to limit unnecessary opioid prescriptions. The investigators propose a randomized controlled non-inferiority trial of women with preeclampsia comparing a postpartum analgesic protocol that includes NSAIDs, to one that excludes them. The central hypothesis is that NSAID use does not worsen hypertensive diseases of pregnancy.

Conditions

• Preeclampsia Severe
• Preeclampsia Postpartum

Interventions

Type	Name	Description
DRUG	Ibuprofen 600 mg	NSAID pain medication to be used in the experimental bundle for postpartum analgesia
DRUG	Ketorolac	NSAID analgesic to be used in the experimental bundle for postpartum analgesia in patients who underwent cesarean section
DRUG	Acetaminophen	Analgesic medication to be used in both treatment arms
DRUG	Oxycodone	Analgesic medication to be used in both treatment arms

Timeline

• Start date: 2019-06-10
• Primary completion: 2025-07-31
• Completion: 2025-09-30
• First posted: 2019-06-07
• Last updated: 2025-12-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study