Individualized Compared With Standard Postdischarge Oxycodone Prescribing After Cesarean Birth: A Randomized Controlled Trial

Abstract

Objective: To evaluate whether individualized postdischarge oxycodone prescribing guided by inpatient opioid use reduces the number of unused opioid tablets after cesarean birth.

Methods: We conducted a randomized, controlled trial of women aged 18 years or older undergoing cesarean birth. Participants were randomized at discharge in a 1:1 ratio to a standard (30 tablets of 5 mg oxycodone) or an individualized oxycodone prescription (predicted based on each patient's inpatient opioid use). All women were contacted starting 14 days after cesarean birth to assess number of oxycodone tablets used and adequacy of pain control. The Tennessee Controlled Substance Monitoring Database was accessed to confirm dispensed opioids. The primary outcome was number of unused oxycodone tablets prescribed for pain control after cesarean birth. A total sample size of 160 women was necessary to detect a 30% difference in leftover tablets between groups with 80% power and α of 0.05.

Results: Between June 14, 2017, and August 26, 2017, we screened 323 women and randomized 172. Baseline characteristics and inpatient opioid use were similar between groups. Women in the individualized group were prescribed fewer tablets (14 [interquartile range 12-16] vs 30 [interquartile range 30-30], P<.001) and had 50% fewer unused tablets than women in the standard group (5 [interquartile range 1-8] vs 10 [interquartile range 0-22], P<.001). Overall, 13% (23/172) used no opioids after discharge and 26% (44/172) used all prescribed opioids. There were no differences between the standard and individualized groups in the proportion of women who used no opioids or all opioids and no difference in the proportion of dispensed opioids used (60% [interquartile range 23-100] vs 61% [29-89], P=.93). Women in the individualized group used only half the number of prescribed opioids as women in the standard group (8 [interquartile range 4-14] vs 15 [interquartile range 6-30], P<.001). Patient-reported pain outcomes did not differ significantly by group.

Conclusion: Individualized opioid prescribing based on inpatient use reduces the number of unused oxycodone tablets compared with standard prescribing.

Clinical trials registration: ClinicalTrials.gov, NCT03168425.

Figures

Figure 1

Flow diagram of study participation. The exclusion categories are not mutually exclusive.

Figure 2

Total oxycodone tablets (5 mg) unused for each patient in standard compared with individualized groups sorted in descending order.

Figure 3

Distribution of patient responses endorsing a negative pain experience by study group.