drugset / Trial / NCT03472521

Prevention of Persistent Opioid Use in Mothers

NCT03472521 ↗

Phase 4 Completed 78 enrolled Stanford University
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Our previous work has identified the group of women at risk for prolonged pain, opioid use and poor functional recovery after childbirth. The optimal intervention to mitigate this risk is unknown. We propose to test an analgesic adjutant that is commonly used for post-operative pain compared to placebo to improve post-partum recovery.

Timeline

Start
2018-09-17
Primary completion
2020-07-02
Completion
2021-04-10

Outcome

Missed primary endpoint

paper There was no difference in time to opioid cessation between patients who were randomly assigned to be treated with gabapentin PMID 37043404 ↗

paper The hazard ratio was 1.1 (95% confidence interval [CI], 0.67-1.8), P = .65. PMID 37043404 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Gabapentin Unknown 300 mg —