Sufentanil Sublingual Tablet 30 mcg for the Management of Pain Following Abdominal Surgery: A Randomized, Placebo‐Controlled, Phase‐3 Study

Abstract

Background: Results from a phase-3, prospective, randomized, double-blind, placebo-controlled trial evaluating sufentanil sublingual tablet 30 mcg (SST) for the management of pain after ambulatory abdominal surgery are presented. Methods: Adults with American Society of Anesthesiologists status 1 to 3 scheduled to undergo abdominoplasty, open tension-free inguinal hernioplasty, or laparoscopic abdominal surgery under general or spinal anesthesia that did not include intrathecal opioids during the operation were eligible. Opioid-tolerant patients were excluded. The primary endpoint was the time-weighted summed pain intensity difference to baseline (SPID) over 12 hours. Secondary endpoints included SPID over 24 and 48 hours, total pain relief, and patient and healthcare professional (HCP) global assessments. Results: Overall, 161 patients were randomized to SST (N = 107) or placebo (N = 54); pain scores were recorded for up to 48 hours. SPID 12 was higher (greater pain intensity reduction from baseline) in the SST group compared with placebo (25.8 vs. 13.1; P < 0.001, with a difference of 12.7 [95% confidence interval 7.16, 18.23]). In the SST group, a greater proportion of patients and HCPs responded "good" or "excellent" on the global assessments compared with placebo (P < 0.001 for both). There was a numerically, but not statistically, higher incidence of nausea and headache in the SST group. Conclusions: In patients following abdominal surgery in an ambulatory care setting, SST was an effective opioid analgesic in postoperative pain management. In addition, SST was well tolerated with mild-to-moderate side effects, similar to those found in placebo-treated patients. &

Efficacy and Safety of Intravenous Meloxicam in Subjects with Moderate-to-severe Pain Following Abdominoplasty

“…The high proportion of placebo subjects who used rescue medications in this study contrasts with 2 recent studies that evaluated acute pain after abdominal surgery. 18 , 19 In the 2 studies, approximately 64% of placebo subjects used ≥ 1 dose of rescue medication compared with 89.9% of placebo subjects in the current study.…”

“…Abdominoplasty is a relatively new model of moderate to severe postsurgical pain lasting > 24 hours postprocedure. 18 , 19 This model was thought to be a good choice for this study because (1) the soft tissue dissection employed for abdominoplasty is quite extensive and as such represents a clinical scenario that can be extrapolated to other large/major soft-tissue surgeries; (2) recruitment into the model is relatively rapid; (3) rigid experimental controls can be employed to reduce patient-to-patient and site-to-site variability without sacrificing subject safety; and (4) the surgery has a low complication rate and a high patient satisfaction rate. 20 , 21 …”

Sublingual analgesia: a promising proposal for the treatment of pain

“…Opioid tolerant patients are better able to tolerate variations in the plasma level of drug than opioid naïve patients, so the safety of sublingual opioids has been more easily established in these patients than in opioid naïve patients. Sublingual opioids for acute pain have generally not been well described in non-cancer breakthrough pain, with the exception of sufentanil [8][9][10][11][12]. The described onsets of pain relief are all defined differently in the available research, with some listing the first time the patient was reassessed and others the time at which any relief was detected, making comparisons between agents and studies difficult.…”

“…Ice chips may be administered if the patient complains for excessive dry mouth. This medication should only be given in a monitored setting and isn't indicated for outpatient use [10][11][12].…”

“…Several studies of this medication have found significant pain relief at 15 minutes increasing until 60 minutes after administration [10][11][12]. With adverse events like other opioid medications.…”