Acute moderate to severe postoperative pain
Conditions
Interventions
Trade Name: Zalviso®
Pharmaceutical Form: Sublingual tablet
INN or Proposed INN: SUFENTANIL CITRATE
CAS Number: 60561-17-3
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration n
Sponsors
GRUNENTHAL PHARMA S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.The patient has provided written informed consent and signed the IRB approved consent form. 2.The patient is an adult aged = 18 years old. 3.The patient is scheduled to undergo surgery, and is expected to remain hospitalized and have acute moderate to severe postoperative pain requiring parenteral opioids for at least 48 hours after surgery. 4.The patient has visual and cognitive ability to use the Zalviso® administration device correctly. 5.Treatment with Zalviso® according to the Summary of Product characteristics is appropriate for the patient. 6.Female patients of childbearing potential must be using an effective method of birth control. Just before the start of treatment with Zalviso®, patients must fulfill all the following inclusion criteria to continue in the study: 1.The patient has had a pain intensity =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1.The patient has hypersensitivity to the active substance or to any other ingredients of the sublingual tablet. 2.The patient has significant respiratory depression, that is, an arterial oxygen saturation by pulse oximetry (SpO2) that cannot be maintained at 95% or greater with or without supplemental oxygen. 3.The patient has current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure. 4.The patient has a medical condition that, in the Investigator’s opinion, could adversely impact the patient’s participation or safety, conduct of the study, or interfere with the pain assessments, including chronic pain or active infection. 5.The patient is deemed by the Investigator to be unable to use the Zalviso® administration device correctly. 6.The patient requires an additional scheduled surgical procedure within 72 hours of the surgery. 7.The patient has received surgical premedication with long-acting opioid analgesics. 8.The patient is receiving or has received monoamine oxidase inhibitors within 14 days before the study entry. 9.The patient has participated in a clinical trial of an investigational drug or device within 30 days of screening visit or is scheduled to receive an investigational product while participating in this study. 10.The patient is pregnant. Just before the start of treatment with Zalviso®, patients must not meet any of the following exclusion criteria to continue in the study: 1.The patient is not awake, not breathing spontaneously or has a respiratory rate that is less than 8 breaths per minute or greater than 24 breaths per minute. 2.The patient is not able to answer questions and follow commands. 3.The patient is vomiting and not responsive to standard treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the effectiveness of Zalviso® for the management of acute postoperative pain by using a Patient Global Assessment (PGA) of the method of pain control.;Secondary Objective: •To evaluate the effectiveness of Zalviso® for the management of acute postoperative pain by using a Healthcare Professional Global Assessment of the method of pain control. •To assess the pain intensity during treatment with Zalviso® by using a 0-10 NRS •To assess the quality of sleep during treatment with Zalviso® by using a 0-10 NRS. •To evaluate the safety and tolerability of Zalviso®. •To assess the ease of use of the device by using the time and personnel required to train patients about its use and the Ease of Care questionnaire. •To obtain data about patients receiving patient controlled analgesia with Zalviso®, (demographics , details of the surgery and perioperative prescribed concomitant medication, patient mobilization/mobility after surgery, and quality of recovery after surgery, by using the Quality of Recovery-15 questionnaire •To obtain data on health care resource utilization by patients treated with Zalviso® over a period of up to 72 hours.;Primary end point(s): The primary endpoint is the success rate on the PGA, defined as the proportion of patients with a response of “good” or “excellent” in the PGA of the method of pain control, on the second postoperative day (the closest assessment to 48 hours after handing over the device to the patient).;Timepoint(s) of evaluation of this end point: the closest assessment to 48 hours after handing over the device to the patient | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Success rate on the PGA, defined as the proportion of patients with a response of “good” or “excellent” in the PGA of the method of pain control, on the day of surgery and the first and third postoperative days. •Success rate on the HPGA, defined as the proportion of healthcare professionals with a response of “good” or “excellent” in the HPGA of the method of pain control, on the day of surgery and the first, second and third postoperative days. •Total score on the Ease of Care (EOC) questionnaire completed by the nurse and the patient at the end of treatment. •Pain intensity on a 0-10 Numerical Rating Scale (NRS) at several time points: when the device is handed over to the patient, 1, 2, 3, 4, 8, 12, 16, 20, 24 hours after handing over the device to the patient, twice a day in the first to (at most) third postoperative days and at the end of treatment. •Worst pain intensity on the day of surgery and the first to (at most) third postoperative days. •Percentage of time with severe pain (pain intensity =7) on the day of surgery and the first to (at most) third postoperative days. •Time-weighed summed pain intensity difference over the first 24 hours (SPID24) after handing over the device to the patient. •Quality of sleep on a 0-10 NRS in the first to (at most) third postoperative days. •Patient mobility/mobilization after surgery on the day of surgery and the first to (at most) third postoperative days. •QoR-15 score at the end of treatment. •Resource utilization. •Adverse events and incidents with the device;Timepoint(s) of evaluation of this end point: 24, 48 and 72 hours after handing over the device to the patient | — |
Countries
Spain
Contacts
Public ContactAna Leal
GRUNENTHAL PHARMA S.A.
Outcome results
None listed