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A multicenter clinical study on the efficacy and safety of hydromorphone for analgesia in emergency department patients

A multicenter clinical study on the efficacy and safety of hydromorphone for analgesia in emergency department patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600124095
Enrollment
Unknown
Registered
2026-05-07
Start date
2026-05-07
Completion date
Unknown
Last updated
2026-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult patients in the emergency department who require treatment with opioid analgesics

Interventions

Trial Group:Hydrochloric Acid Hydromorphone Injection. Intravenous maintenance dose 2-5µg/kg/h for non-mechanical ventilation patients
8-15µg/kg/h for mechanical ventilation patients. Target NRS score <=3 points.
Control Group:Citric Acid Fentanyl Injection. Intravenous maintenance dose 0.7-10µg/kg/h. Target NRS score <=3 points.

Sponsors

Xi'an Jiaotong University Second Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Participants must be at least 18 years of age. There will be no restrictions based on gender. 2.Emergency department patients who require opioid analgesic therapy. 3.Informed consent was obtained from the patient or their legal guardian.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women. 2.Known allergy or hypersensitivity to any of the study drugs. 3.Use of any analgesic medications other than hydromorphone or fentanyl within the previous week. 4.History of chronic opioid use or opioid addiction. 5.Hemodynamic or respiratory instability, defined as systolic blood pressure < 90 mm Hg, heart rate < 50 beats per minute, or oxygen saturation < 95%. 6.Intoxication with alcohol or other drugs. 7.Symptoms of respiratory depression, or a diagnosis of acute or severe bronchial asthma. 8.Paralytic or potentially obstructed bowel (e.g., patients with or at risk for gastrointestinal obstruction, particularly paralytic ileus). 9.Hearing or visual impairment, or any other condition that may severely interfere with the collection of study data. 10.Patients with psychiatric or neurological disorders, cognitive or consciousness impairments, who are unable to provide reliable expressions. 11.Previous participation in this study or concurrent participation in any other clinical trial.

Design outcomes

Primary

MeasureTime frame
Overall patient satisfaction in the two groups;

Secondary

MeasureTime frame
Time to a 2-point reduction in the NRS score from baseline;Analgesic onset time;The number of cases that achieved the target analgesic score (NRS score <= 3);Volume of fluid required for resuscitation;Medical expense;Emergency department length of stay;Vital signs;Total dosage of analgesic drugs used during the study period;

Countries

China

Contacts

Public ContactZhang Zhengliang

Xi'an Jiaotong University Second Affiliated Hospital

18991204398@126.com+86 29 87679388

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 16, 2026