Objectives

To determine whether a patient-specific analgesic treatment or a weight-based analgesic treatment is more effective in relieving pain in individuals with sickle cell disease being treated in an emergency department.

Background

Individuals with sickle cell disease (SCD) frequently experience acute pain, often referred to as vaso-occlusive crises (VOC) that may require treatment in an emergency department (ED). Evidence-based recommendations on the treatment of VOC exist and include rapid, aggressive treatment of pain with opioids. In practice, patients often report inadequate or delayed treatment of pain, and ED providers report not believing patients are experiencing severe sickle cell pain that warrants opioid analgesia. To overcome these barriers, recent recommendations call for using individualized pain plans when possible.

COMPARE-VOE was initiated to compare whether treatment of individuals with SCD at an ED using a patient-specific protocol (PSP) written by their SCD provider or a weight-based dosing of parenteral opioid medication was more effective in relieving pain.

Participants

Eligible participants were aged 18 years or older with Sickle Cell Disease of one of the following genotypes: Hgb SS (sickle cell anemia), SC (Sickle hemoglobin-c), and SB+ (sickle Beta-Plus thalassemia) and SB- (sickle Beta zero thalassemia). Exclusion criteria included individuals determined to not benefit from opioids or with a COVID-19 infection, as well as out-patient use of buprenorphine or methadone.

A total of 328 eligible participants were randomized; 162 were randomized to a PSP and 166 were randomized to a weight-based protocol. Of those with an ED visit during the study period, 54 participants were in the PSP group and 50 participants were in the weight-based protocol group.

Design

COMPARE-VOE was a phase III, multi-center, single-blinded randomized trial. Randomization to a PSP or a weight-based protocol occurred prior to the ED visit. Data from only one ED visit was collected for each enrolled participant. For participants randomized to the weight-based protocol, doses were determined using weight ranges. For participants randomized to a PSP, their SCD provider used a calculator to determine the initial opioid analgesic and dose. The study was stopped early due to the impact of COVID-19.

Baseline data were collected at the time of randomization, including completion of a demographics survey and medical history. During the ED visit, the research staff obtained pain intensity scores, vital signs, and safety measurements every 30 minutes until one of the following were met, whichever came first: 1) decision to discharge home, 2) decision to admit to the hospital or assigned observation status for continued pain management, or 3) after six hours of treatment for VOC. After completion of the study visit, research staff collected data on all opioids and non-opioids, doses, routes, and timing of administration.

The primary endpoint was the change in pain scores in the ED from time of placement in treatment area to time of disposition (hospitalization, discharged home, or assigned to observation status) or a maximum treatment duration of 6 hours.

Conclusions

Participants treated with a patient-specific protocol had a shorter length of stay in the emergency department. Participants in both groups experienced good pain relief without significant side effects.

Tanabe P, Ibemere S, Pierce AE, et al. A comparison of the effect of patient-specific versus weight-based protocols to treat vaso-occlusive episodes in the emergency department. Acad Emerg Med. 2023;30(12):1210-1222. doi:10.1111/acem.14805

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