Hydromorphone, Analgesia, ICU
Conditions
Brief summary
Hydromorphone has a clear analgesic effect, and has few advantages in respiratory depression and gastrointestinal motility. The study will further explore the continuous pumping-dose of hydromorphone for ICU non-mechanical ventilation patients and monitor its effective plasma concentration as well as evaluates the safety and effectiveness of hydromorphone for ICU non-mechanical ventilation patients.
Interventions
DRUGHydromorphone
Intravenous analgesia using hydromorphone in ICU patients with non-mechanical ventilation(NS 40ML+ hydromorphone 10mg ，IV-Pump)
DRUGFentanyl
Intravenous analgesia using fentanyl in ICU patients with non-mechanical ventilation(NS 40ML+ fentanyl 0.5mg, IV-Pump)
DRUGButorphanol
Intravenous analgesia using butorphanol in ICU patients with non-mechanical ventilation(NS 40ML+ butorphanol 10mg，IV-Pump)
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years old; * Non-mechanical ventilation patients with expected ICU stay time \>24h * People with moderate to severe pain who need immediate analgesic treatment (NRS ≥ 4 or BPS ≥ 5 points, CPOT ≥ 3);
Exclusion criteria
* During pregnancy or breastfeeding； * Confirmed acute severe intracranial or spinal nerve disease caused by vascular, infection, intracranial dilation or injury; * Non-compensatory acute circulatory failure (severe hypotension with MAP\<55 mmHg even if sufficient fluid resuscitation and vascular compression therapy); * Severe bradycardia (heart rate\<55 beats/min) or heart block of degree II-III (excluding those with pacemakers installed); * Unable to obtain pain scores or any other conditions that may seriously interfere with the collection of research data; * Have used analgesics other than remifentanil during mechanical ventilation in the ICU; * Having a history of long-term use of opioid drugs or opioid addiction; * Known allergy history of experimental drugs; * Suffering from severe or acute asthma, or respiratory depression caused by severe carbon dioxide retention, head injury, and intracranial damage; * Danger period intestinal obstruction (present or at risk of progression to gastrointestinal obstruction, especially in patients with paralytic intestinal obstruction); * Having participated in this study or any other intervention studies (any study that assigns patients to different treatment groups); * Unsuitable to participate in this experiment according to the judgment of the researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| successful analgesic proportion | From date of using the intervention drugs until the date of leaving from icu, up to 28 days | Proportion of patients in each group who reached the target analgesia score range |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | From hospital admission to hospital discharge or death, assessed up to 60 days. | Duration from hospital admission to hospital discharge or death, measured in days. |
| Mortality rate in hospital | From hospital admission to hospital discharge or death, assessed up to 60 days. | Death from any cause before hospital discharge. |
| ICU mortality | From ICU admission to ICU discharge or death, assessed up to 60 days. | Death from any cause before ICU discharge. |
| cost during ICU | from the date of entering hospital until the date of discharging or death from any cause，up to 60 days | Hospitalization expenses during ICU |
| Score | From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days | analgesia score, such as CPOT or NRS |
| dose of analgesics | From date of using the intervention drugs until the date of stopping using intervention drugs, up to 28 days | total dose of analgesics during the study |
| Adverse event | From date of using the intervention drugs until the date of discharge or death from any cause, up to 60 days | Adverse event during the study, including hypotension.et |
| ICU stay | from the date of entering icu until the date of leaving icu or death from any cause, up to 28 days. | duration of stay in ICU |
| Mechanical ventilation-free days | From date of using the intervention drugs until the date of retrachealing intubation,leaving icu or death from any cause, up to 28 days | Duration without mechanical ventilation during the use of analgesics |
| Days without delirium or coma | From date of using the intervention drugs until the date of discharge or death from any cause, up to 28 days | Number of days in which the patient did not experience delirium or coma |
Countries
China
Outcome results
None listed