About this trial
The analgesic effect of nalbuphine hydrochloride injection will be evaluated in a multicenter, randomized, single-blind, parallel, positive-controlled approach in two steps: step 1, to explore the optimal dosage of nalbuphine hydrochloride injection with 2 experimental arms and 1 positive control and step 2, to evaluate the effectiveness and safety of nalbuphine hydrochloride injection in mechanically ventilated ICU patients at a dosage determined in step 1 with the same positive control.
Eligibility criteria
Qualifiers
ICU patients who are intubated are expected to require mechanical ventilation for more than 6h
patients or their guardians have a full understanding of the purpose and significance of this trial, and voluntarily participate in this clinical trial and sign an informed consent form
Disqualifiers
Allergy or unsuitability to any composition of study drugs or propofol
Living expectancy of less than 48 hours
Neurological disorder and any other condition interfering with sedation assessment
Gastrointestinal obstruction
Trial design
Treatments tested in this trial
- Nalbuphine hydrochloride injection
- Hydromorphone hydrochloride injection
Treatment groups
Sponsors and collaborators
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead sponsor
Yichang Humanwell Pharmaceutical Co., Ltd., China
Collaborator