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Hydromorphone combined with butorphanol for analgesia in ICU parturients: a single center, randomized, superior clinical study

Hydromorphone combined with butorphanol for analgesia in ICU parturients: a single center, randomized, superior clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061745
Enrollment
Unknown
Registered
2022-07-02
Start date
2023-03-31
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

analgesia

Interventions

Test group:Hydromorphone injection + Butorphanol Tartrate Injection
control group: Butorphanol Tartrate Injection

Sponsors

The Third Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Diagnostic criteria: invasive mechanical ventilation: positive pressure ventilation applied by trachea or tracheotomy supplemented by ventilator. Inclusion criteria: 1. Age >= 18 years old; 2. Estimated ICU stay time > 24h; 3. Moderate and severe pain requiring immediate analgesic treatment (cpot>= 3 or BPS >= 5); 4. Obtain the informed consent of the subject or legal representative;.

Exclusion criteria

Exclusion criteria: Exclusion criteria: 1. During lactation; 2. Acute severe intracranial or spinal nerve diseases caused by vascular, infection, intracranial expansion or injury have been confirmed; 3. Uncompensated acute circulatory failure during randomization (severe hypotension with map < 50 mmHg despite adequate fluid resuscitation and vasopressor therapy); 4. Severe bradycardia (heart rate < 50 beats/min) or degree II-III cardiac block (except when cardiac pacemaker is installed) 5. Hearing or vision loss, or any other condition that may seriously interfere with the collection of study data; 6. Have a long-term history of opioid use or opioid addiction 7. Have a known history of allergy to any study drug; 8. patients with severe or acute asthma, or respiratory depression caused by severe carbon dioxide retention, head injury and intracranial damage; 9. Intestinal obstruction at risk (patients with or at risk of progression to gastrointestinal obstruction, especially paralytic intestinal obstruction); 10. Liver failure: child Pugh grade C cirrhosis, acute liver failure, severe and existing substantive liver disease with clinically significant portal hypertension; 11. Renal failure: defined as GFR < 15ml /(min · 1.73m2) or receiving dialysis treatment; 12. Participate in any other interventional study at the same time (any study that assigns subjects to different treatment groups and/or performs unconventional diagnostic or monitoring procedures);

Design outcomes

Primary

MeasureTime frame
Primary endpoint: the proportion of patients in each group who reached the target analgesic score range [cpot score < 3 (unable to express autonomously), NRS score, with a target value of < 4 (able to express autonomously)] at all time points;

Countries

CHINA

Contacts

Public ContactWenting Xu
xurang@126.com+86 13826483480

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026