Intranasal Sufentanil Versus Intravenous Morphine for Acute Pain in the Emergency Department: A Randomized Pilot Trial.

BACKGROUND: Patients in the United States frequently seek medical attention in the emergency department (ED) to address their pain. The intranasal (i.n.) route provides a safe, effective, and painless alternative method of drug administration. Sufentanil is an inexpensive synthetic opioid with a high therapeutic index and rapid onset of action, making it an attractive agent for management of acute pain in the ED. OBJECTIVE: The objective of our study was to evaluate the safety and efficacy of i.n. sufentanil as the primary analgesic for acute pain in the ED. METHODS: This was a single-center, prospective, randomized, double-blind, double-dummy, controlled trial that evaluated the use of i.n. sufentanil 0.7 µg/kg via mucosal atomizer device vs. intravenous morphine 0.1 mg/kg in adult patients who presented to the ED with acute pain. The primary outcome was patient's pain score at 10 min after administration of intervention. Secondary outcomes were adverse events, the need for rescue analgesia, and patient satisfaction after treatment. RESULTS: Thirty patients were enrolled in each group. There was no significant difference in pain scores at 10 min after administration of intervention (sufentanil: 2.0, interquartile range = 2.0-3.3 vs. morphine: 3.0, interquartile range = 2.0-5.3, p = 0.198). No serious adverse events were reported. Rescue analgesia was not requested in either group. No significant difference in median satisfaction scores was found. CONCLUSION: The use of i.n. sufentanil at 0.7 µg/kg/dose resulted in rapid and safe analgesia with comparable efficacy to i.v. morphine for up to 30 min in patients who presented with acute pain in the ED.

Development and validation of an HPLC/MS/MS method for the determination of sufentanil and morphine in human plasma.

A sensitive and fast HPLC/MS/MS method for measurement of sufentanil and morphine in plasma was developed and validated. A single liquid-liquid extraction in alkaline medium was used for the cleanup of plasma, and fentanyl was added as an internal standard (IS). The analyses were carried out using a C18 column and the mobile phase acetonitrile-5 mM ammonium acetate + 0.25% formic acid (70 + 30, v/v). The triple-quadrupole mass spectrometer equipped with an electrospray source in positive mode was set up in the selective reaction monitoring mode to detect precursor --> product ion transition 387.0 > 238.0, 285.7 > 165.1, and 337.0 > 188.0 for sufentanil, morphine, and IS, respectively. The method was linear in the 0.05 (LOQ) - 500 ng/mL range for sufentanil and 10 (LOQ) - 1000 ng/mL range for morphine. Good selectivity, linearity, precision, accuracy, and robustness were obtained for the HPLC/MS/MS method. The proposed method was successfully applied for the determination of sufentanil and morphine in patients undergoing cardiac surgery.

Analgesic efficacy of sufentanil in dressings after surgical treatment of burn wounds.

BACKGROUND: The aim of this study was to assess the analgesic efficacy of sufentanil in dressings after surgical treatment of burn wounds. PATIENTS AND METHODS: Twenty adult patients, who underwent surgical treatment of third-degree burn wounds under general anesthesia, were included. Two of the patients underwent surgery twice. During surgery, patients received 50-100 µg fentanyl every 20-30 min and, after surgery, patients received 100 mg ketoprofen twice daily. Additionally, ten patients (group 1) received 50 µg sufentanil added to the burn wound dressings soaked in octenidine and phenoxyethanol while 10 patients (group 2) received 25 µg sufentanil added to the same dressings. The rescue analgesic, which was administered when pain intensified, was 5 mg subcutaneous morphine. Plasma sufentanil concentrations were assayed at 1, 2, 3, and 6 h after surgery completion and when pain was reported, along with pain intensity evaluation. RESULTS: Sufentanil was not detected in the serum of any patients. Rescue morphine was given during the postoperative period (24 h) in one patient in group 1 (who underwent surgery twice) and three patients in group 2. The mean sufentanil concentration in dressings was higher in group 1 (0.13 ± 0.03) than group 2 (0.06 ± 0.03 µg/mL; p < 0.001). The group 1 patient who received rescue morphine had a sufentanil concentration of 0.10 µg/mL, which was the lowest concentration in group 1. Group 2 patients who received rescue morphine had sufentanil concentrations of at least two-fold lower (0.03-0.05 µg/mL). No adverse effects were observed. CONCLUSIONS: Sufentanil in dressings after burn wound surgery provides effective and safe analgesia and the sufentanil concentration in dressings should be ≥0.10 µg/mL in a solution of octenidine and phenoxyethanol.

Intranasal sufentanil given in the emergency department triage zone for severe acute traumatic pain: a randomized double-blind controlled trial.

The goal of our study was to determine if an intranasal (IN) dose of sufentanil delivered in the ED triage zone would improve the management of severely painful patients. We performed a randomized, double blind and placebo-controlled trial on adult patients suffering from an acute severe pain (≥ 6/10) consecutive to an isolated limb injury. We compared 2 analgesic strategies: the usual pain treatment with IV-only multimodal analgesics (IVMA) including IV opioids if needed (control group) and another strategy (active group) based on a single dose of IN sufentanil (0.4 µg/kg) given at triage and followed by IV multimodal analgesia. Our primary outcome was the proportion of patients reaching pain-relief (≤ 3/10) 30 min after IN injection at triage. Secondary outcomes were rates of adverse events, frequency of clinical interventions required by these events, and satisfaction of patients. A total of 144 adult participants completed the study, 72 in each group. Compared with usual IV-only pain management, the analgesic strategy initiated in triage zone with a dose of IN sufentanil increased the proportion of patients reaching pain relief in 30 min: 72.2% versus 51.4%, in our trial (p = 0.01 and number needed to treat of 5). There was no serious adverse event (AE) in both groups. Patients who received IN sufentanil experienced more frequently minor opiate side effects. Proportion of respiratory AEs was higher in the active group (12.5% of bradypnea < 10 cycles per minute versus 1.4%) but these events were of mild severity, as only 2 participants (one in each group) received temporary low dose oxygen therapy, and none required naloxone. Lengths of stay in the ED were similar in both groups, as well as satisfaction of patients (above 9/10) and pain scores at discharge (< 2/10). We found that a single dose of IN sufentanil delivered in the ED triage zone significantly increases the proportion of severely painful patients reaching painrelief in 30 min, compared to usual analgesia with IV-only multimodal analgesia.

Labor pain relief using bupivacaine and sufentanil: patient controlled epidural analgesia versus intermittent injections.

OBJECTIVES: To determine whether the use of patient-controlled epidural analgesia (PCEA) versus intermittent injections (CIT) resulted in local anesthetic dose reduction. STUDY DESIGN: PCEA and CIT using a mixture of 0.125% bupivacaine with sufentanil 1 or 0.75 microgram/ml were compared in 60 and 195 parturients, respectively. Assessments included pain scores, local anesthetic consumption, degree of motor blockade, type of delivery and neonatal outcome. Statistical analysis was done using Student's t test and Chi-squares. RESULTS: PCEA and CIT provided effective analgesia during labor and delivery. A higher dose of opioid significantly reduced the use of local anesthetic solution in PCEA-patients. There was no difference in motor blockade, type of delivery and neonatal outcome. CONCLUSION: Patient-controlled epidural analgesia is an effective, safe and acceptable alternative to conventional intermittent epidural injections for pain relief during labor and delivery.

Comparison of two techniques of narcotic-induced anesthesia for use during recording of magnetic motor evoked potentials in dogs.

OBJECTIVE: To compare 2 types of narcotic-induced anesthesia for recording of transcranial magnetic motor evoked potentials (TMMEP) in dogs. DESIGN: The effect of different doses of sufentanil and midazolam and of sufentanil and nitrous oxide on onset latencies and peak-to-peak, amplitudes of TMMEP was evaluated and compared. ANIMALS: 18 neurologically normal dogs. PROCEDURE: Premedication with droperidol and fentanyl. Induction and maintenance of anesthesia either with sufentanil and midazolam or with sufentanil and nitrous oxide. Recording of TMMEP from the extensor carpi radialis muscle of the forelimb and from the cranial tibial muscle of the hind limb. RESULTS: Both types of narcotic anesthesia induced dose-dependent suppression of TMMEP; compared with baseline recordings, latencies increased, amplitudes decreased, and reproducibility became poorer with increasing dose of the anesthetics. Using surgical-depth doses of the anesthetics, TMMEP could still be recorded in all dogs with sufentanil and nitrous oxide, but not with sufentanil and midazolam anesthesia. CONCLUSIONS: Sufentanil and nitrous oxide anesthesia was superior to sufentanil and midazolam anesthesia for TMMEP recording. CLINICAL RELEVANCE: In small animal medicine, and in dogs in particular, spinal cord diseases are among the most frequently encountered neurologic disorders. The development of techniques for recording TMMEP in anesthetized dogs allows noninvasive evaluation of transmission along descending motor pathways of the spinal cord.