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Author Notes:

Email Address : Carlton Dampier :cdampie@emory.edu.

Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health.

The SCD CRN IMPROVE Trial was registered with clinicaltrials.gov (#NCT00999245).

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Research Funding:

This publication was made possible by Grant Number U10HL083721 from the National Heart, Lung, and Blood Institute, National Institutes of Health.

Keywords:

  • sickle cell disease
  • opioids
  • PCA
  • clinical trial

Opioid patient controlled analgesia use during the initial experience with the IMPROVE PCA trial: A phase III analgesic trial for hospitalized sickle cell patients with painful episodes

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Journal Title:

American Journal of Hematology

Volume:

Volume 86, Number 12

Publisher:

, Pages E70-E73

Type of Work:

Article | Final Publisher PDF

Abstract:

Opioid analgesics administered by patient-controlled analgesia (PCA)are frequently used for pain relief in children and adults with sickle cell disease (SCD) hospitalized for persistent vaso-occlusive pain, but optimum opioid dosing is not known. To better define PCA dosing recommendations,a multi-center phase III clinical trial was conducted comparing two alternative opioid PCA dosing strategies (HDLI—higher demand dose with low constant infusion or LDHI—lower demand dose and higher constant infusion) in 38 subjects who completed randomization prior to trial closure. Total opioid utilization (morphine equivalents,mg/kg) in 22 adults was 11.6 ± 2.6 and 4.7 ± 0.9 in the HDLI andin the LDHI arms, respectively, and in 12 children it was 3.7 ± 1.0 and 5.8 ± 2.2, respectively. Opioid-related symptoms were mild and similar in both PCA arms (mean daily opioid symptom intensity score: HDLI0.9 ± 0.1, LDHI 0.9 ± 0.2). The slow enrollment and early study termination limited conclusions regarding superiority of either treatment regimen. This study adds to our understanding of opioid PCA usage in SCD. Future clinical trial protocol designs for opioid PCA may need to consider potential differences between adults and children in PCA usage.

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© Wiley-Liss, Inc.

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