Oxycodone Ingestion Patterns in Acute Fracture Pain With Digital Pills

Chai, Peter R. MD, MMS; Carreiro, Stephanie MD; Innes, Brendan J. BS; Chapman, Brittany BS; Schreiber, Kristin L. MD, PhD; Edwards, Robert R. PhD; Carrico, Adam W. PhD; Boyer, Edward W. MD, PhD

Disclosures

Anesth Analg. 2017;125(6):2105-2112. 

In This Article

Results

During the study period, 26 individuals were eligible and approached for the study (Figure 2). Ten individuals declined to participate; the majority of nonconsenting individuals reported that they preferred a different opioid formulation that we did not compound with the digital pill (N = 2), that they did not want opioids on discharge (N = 2), that they did not intend to participate in the follow-up interview (N = 1), or that they did not reside in our region (N = 1). None refused participation based on concerns related to ingesting a biosensor. There were no deviations from the study protocol. Of the 16 individuals consented, 15 completed the study. The 1 individual who did not complete the study reported that excessive pain prevented him from recharging the battery of the reader. The mean age of study participants was 45 years; 60% (N = 9) identified as male, while 40% (N = 7) identified as female (Table 1). Seven participants ultimately required operative repair of their fracture, while 8 participants were treated nonoperatively.

Figure 2.

Study schematic and enrollment pattern. CRC indicates clinical research center.

The digital pill recorded a total of 112 ingestion events (Table 2); pill counts demonstrated a total of 134 ingestions (84% accuracy). All missed ingestion events were isolated to 2 study participants who ingested digital pills without wearing the reader, or did not recharge the reader due to severe pain. The digital pill system detected 34 simultaneous ingestion events where participants ingested 2 pills at 1 time. Eighteen of these episodes (52%) occurred in the first 48 hours after discharge.

Participants ingested a median of 6 (3–9) oxycodone digital pills (45-mg morphine equivalents) during the study period (Figure 3). The majority, 82%, of cumulative oxycodone doses per participant was ingested in the first 72 hours. After 3 days, 46% (N = 7) participants had stopped taking oxycodone. Most participants self-tapered their oxycodone dosing intervals over the first 72 hours after discharge (Figure 4). In the first 24 hours after discharge, participants ingested oxycodone digital pills on average every 12 hours, and then typically lengthened their dosing interval to 1 ingestion daily at 48 hours after discharge. Participants returned a mean of 12 oxycodone digital pills at the end of the study period.

Figure 3.

Median oxycodone ingestion events in all study participants (A), in participants who ultimately underwent operative repair (B), and in participants who ultimately underwent nonoperative repair (C). ED indicates emergency department.

Figure 4.

Ingestion events recorded by the oxycodone digital pill. "X" denotes recorded ingestion event, and "S" denotes recorded ingestion event that is part of a simultaneous (ingested 2 pills at 1 time) ingestion event recorded by the digital pill.

Participants who required operative repair (N = 7) ingested a median of 8 (range: 6–11) oxycodone digital pills (60-mg morphine equivalents); 84% of the cumulative dose was ingested in the first 72 hours. Six of the 7 participants (86%) with operative fractures remained on oxycodone at 1 week, while 1 participant did not ingest opioids during the study period. Most participants with operative fractures ingested oxycodone digital pills every 8 hours for the first 24 hours before tapering down to every 24 hours at 48 hours after discharge.

Participants with nonoperative fractures (N = 8) ingested a median of 5 (range: 1.5–7) oxycodone digital pills (37.5-mg morphine equivalents); 80% of the cumulative dose was ingested in the first 72 hours. On average, participants ingested oxycodone digital pills once daily for the first 24 hours and had stopped taking oxycodone digital pills 96 hours after their injury. No participants who were managed nonoperatively continued to ingest opioids at the end of the study period.

Most participants (N = 12) self-reported that their pain was well controlled during the study. Ten participants (66%) reported pain that was severe (eg, in the range of 7–10/10), prompting them to use the oxycodone digital pill for the first 72 hours. Although most participants reported they continued to feel pain after 3 days, 10 reported that the intensity of pain had decreased until it was adequately managed with nonsteroidal antiinflammatory drugs and acetaminophen. Of note, 6 participants reported even after their pain had subsided, they continued to ingest oxycodone digital pills in the evening before bedtime as "prophylaxis" against potential episodes of pain in the morning.

Comments

3090D553-9492-4563-8681-AD288FA52ACE

processing....