Jacob L Hutchins1, David Leiman2, Zubaid Rafique3, Karen P DiDonato4, Pamela P Palmer5. 1. Department of Anesthesiology, University of Minnesota, Minneapolis, MN. 2. Department of Surgery, University of Texas at Houston, and HD Research Corp, Houston, TX. 3. Department of Emergency Medicine, Baylor College of Medicine, Ben Taub General Hospital, Houston, TX. 4. Medical Affairs, AcelRx Pharmaceuticals, Redwood City, CA. 5. Medical Affairs, AcelRx Pharmaceuticals, Redwood City, CA. Electronic address: ppalmer@acelrx.com.
Abstract
PURPOSE: To aid nurses in dosing sufentanil sublingual tablet (SST) 30 mcg administered via a single-dose applicator, dosing requirements and efficacy of SST 30 mcg were analyzed across age, sex, race, and body mass index subgroups. DESIGN: Patient characteristics were pooled from three postoperative studies (two placebo-controlled and one open-label) and one open-label emergency department study. Drug dosing and efficacy data were pooled from the postoperative studies. METHODS:Efficacy was assessed through summed pain intensity difference to baseline during 12 hours across subgroups. FINDINGS:Mean (standard deviation) drug doses administered from 0 to 12 hours was 3.9 (2.0) for SST 30 mcg and was less frequent for older (≥65 years) versus younger patients. The summed pain intensity difference to baseline during 12 hours was superior with SST 30 mcg versus placebo across all subgroups. CONCLUSIONS:SST 30 mcg is a sublingual opioid analgesic with efficacy across demographic subgroups.
RCT Entities:
PURPOSE: To aid nurses in dosing sufentanil sublingual tablet (SST) 30 mcg administered via a single-dose applicator, dosing requirements and efficacy of SST 30 mcg were analyzed across age, sex, race, and body mass index subgroups. DESIGN:Patient characteristics were pooled from three postoperative studies (two placebo-controlled and one open-label) and one open-label emergency department study. Drug dosing and efficacy data were pooled from the postoperative studies. METHODS: Efficacy was assessed through summed pain intensity difference to baseline during 12 hours across subgroups. FINDINGS: Mean (standard deviation) drug doses administered from 0 to 12 hours was 3.9 (2.0) for SST 30 mcg and was less frequent for older (≥65 years) versus younger patients. The summed pain intensity difference to baseline during 12 hours was superior with SST 30 mcg versus placebo across all subgroups. CONCLUSIONS: SST 30 mcg is a sublingual opioid analgesic with efficacy across demographic subgroups.