ª 2014 by the American College of Surgeons

Published by Elsevier Inc.

PERIOPERATIVE & CRITICAL CARE

Zalviso� (sufentanil sublingual microtablet system)efficacy and functionality following major abdominalsurgery in young and elderly adult patientsForrest G Ringold, MD, Harold S Minkowitz, MD,Tong-Joo Gan, MD, Keith A Aqua, MD,Pamela P Palmer, MD, PhDAcelRx Pharmaceuticals, Redwood City, CA and Mobile

Infirmary Medical Center, Mobile, AL and Memorial HermanMemorial City Hospital, Houston, TX and Duke UniversityMedical Center, Durham, NC and Atlantic Clinical Research

Collaborative, Lake Worth, FL

INTRODUCTION: Zalviso� (sufentanil sublingual microtabletsystem; SSMS; AcelRx Pharmaceuticals, Redwood City, CA) is anovel handheld, preprogrammed, noninvasive patient-controlled

analgesia (PCA) product under review by the FDA that is designedto allow patients to self-administer sublingual sufentanil 15 mcgmicrotablets with a 20-minute lockout period for the treatmentof moderate-to-severe pain in a hospital setting. The device uses ra-

dio-frequency identification to allow only the patient to activate thedevice, thereby minimizing proxy dosing. The device does notrequire programming and avoids the risk of human factor errors

that occur with IV PCA pump technology.

METHODS: A double-blind, placebo-controlled study of 178 pa-tients at 13 US sites following open abdominal surgery was con-ducted with a 2:1 (SSMS:placebo) randomization. The primaryefficacy variable was the time-weighted summed pain intensity dif-

ference over the 48-hour study period (SPID48). Key secondary ef-ficacy variables included scores from validated patient and nurseease-of-care questionnaires. Morphine IV was used for rescue

analgesia.

RESULTS: A total of 115:57 (SSMS:placebo) received study drug

and were included in the intent-to-treat population. SPID48 wasgreater (better) for SSMS than the same system dispensing placebomicrotablets (105.6 vs 55.6; p¼0.001) and there was no difference

between young versus elderly patients for SPID48 in the SSMSgroup or for device ease-of-care assessment ratings. There wereno differences between SSMS and placebo for any related AE.

CONCLUSIONS: SSMS provides an attractive alternative to IVPCA analgesia, is easy for healthcare professionals to set-up and

for all ages of adult patients to use.

Crystalloid to blood product ratios in hemostaticresuscitation for blunt injury: early balanced ratiosincrease survivalAdarsh Vijay, MD, Ruben Peralta, MD, FACS,Rafael J Consunji, MD, MPH, Ayman El Menyar, MD,HH Abdelrahman, MD, A Parchani, MD, A Zarour, MD,Hassan A Al Thani, MBBCh, FACS, Rifat Latifi, MDHamad Medical Corporation, Doha, Qatar and University ofArizona, Tuscon, AZ

INTRODUCTION: There is no consensus towards the optimal crys-

talloids to blood product ratio or their timing in blunt trauma pa-tient requiring massive transfusion. This study aims to explore the

e131

association between the crystalloid to packed red blood cells

(PRBC), fresh frozen plasma (FFP) and platelet ratios (C:PRBC,C:FFP and C:Plt) and clinical outcomes in blunt injury (BI) pa-tients needing massive transfusion (MT).

METHODS: A retrospective data review from a prospectively

collected MT registry, at a Level I trauma center, was conducted.All BI patients who received �10 units PRBC in their 1st 24 hourswere included. Patients were divided into two groups: survivors [S]

and non-survivors [NS]. Demographic information, clinical char-acteristics and outcome measures were compared and tested fortheir association with the crystalloid to component ratios (L/unit)

at 4 and 24 hours post-injury.

RESULTS: One hundred patients met inclusion criteria, 41 survi-vors and 59 non-survivors. Both groups were similar for baselinedemographic and clinical characteristics. There were no significantdifferences in ACS, AKI, ARDS, VAP or MOF. The comparison

of the mean ratios between the groups at 4 hours showed a statis-tically significant difference for C:PRBC (0.92 vs 0.68, p¼0.0508)and C:Plt (0.84 vs 1.42, p¼0.0018) between S and NS groups. A

significant difference for C:PRBC was also noted at 24 hours (0.58vs 0.46, p¼0.0094). There was a trend towards lower C:FFP in theS group at 4 and 24 hours after injury but but without statistical

significance.

CONCLUSIONS: This study showed an association between ahigher C:PRBC and a lower C:Plt ratio 4 hours post-injury andsurvival of patients with BI.

IL-6 levels are inversely related to blood glucose levels insevere sepsis and septic shockAnja K Jaehne, MD, Emanuel P Rivers, MD, MPH,Ilan S Rubinfeld, MD, FACS, Matilda M Horst, MD,Justin Belsky, MD, Namita Jayaprakash, MDHenry Ford Hospital, Detroit, MI

INTRODUCTION: Severe sepsis and septic shock (SS/SS) havebeen associated with alterations in in glucose metabolism (hypo-

and hyperglycemia). Hyperglycemia is known to activate the in-flammatory cascade. IL-6 is a cytokine and myokine necessary forthe resolution of inflammation. In SS/SS glucose utilization isdecreased and research studies have shown that SS/SS can lead to

insulin resistance in response to elevated cytokines (eg, IL-6) alsoknown as stress hyperglycemia. Additionally studies in the ICUsetting have shown that elevated levels of IL-6 are not only associ-

ated with hyperglycemia but also difficulties in glucose controlwhile patients are treated for SS/SS in the ICU. The aim of thisproject was to examine the early relationship between IL-6 and

glucose at the most proximal point of hospital presentation in pa-tients with SS/SS.

METHODS: We prospectively identified 243 patients and ob-tained specimens in patients presenting with severe sepsis and septic

shock presenting to the Emergency Department (ED). These sam-ples were obtained before intervention after consent was obtained.

http://dx.doi.org/10.1016/j.jamcollsurg.2014.07.736

ISSN 1072-7515/14