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Effects of low dose esmketamine combined with hydromorphone for intravenous controlled analgesia on postoperative pain in children: a randomized controlled study

Effects of low dose esmketamine combined with hydromorphone for intravenous controlled analgesia on postoperative pain in children: a randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064762
Enrollment
Unknown
Registered
2022-10-17
Start date
2022-10-17
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Postoperative pain

Interventions

trial group:PCIA prescription : hydromorphone 0.1mg/Kg/48h combined with esketamine 1 mg/Kg/48h
control group:PCIA prescription:hydromorphone 0.2mg/Kg/48h

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age greater than 3 years but less than 12 years old; 2. ASA classification level 1-2; 3. Patients who plan to undergo elective abdominal surgery under general anesthesia; 4. Parents or guardians agree to use postoperative patient-controlled intravenous analgesia.

Exclusion criteria

Exclusion criteria: 1. Cognitive impairment of parents/caregivers or children resulting in inability to self report pain or answer research questions; 2. Has a history of allergic reactions to opioid drugs, ketamine, Esketamine, or their components in the past; 3. Severe obesity; 4. Severe sleep apnea syndrome; 5. A history of arrhythmia, bronchial asthma, acute upper respiratory tract infection, or the presence or possibility of difficult airways; 6. Abnormal recovery from previous surgical anesthesia; 7. Have a history of chronic pain and long-term use of analgesics; 8. Use analgesics, sedatives, or antipruritic drugs or quinolone antibiotics 24 hours before surgery; 9. Severe liver and kidney dysfunction; 10. ASA level 3 and above.

Design outcomes

Primary

MeasureTime frame
Time weighted mean pain score at 24 h postoperatively;

Secondary

MeasureTime frame
FLACC scoring at 48 h after surgery;Opioid consumption in the first 48 h after surgery;Incidence of nausea and vomiting, hypoventilation, and pruritus within the first 48 h after surgery;Incidence of delirium in the first 3 postoperative days;

Countries

China

Contacts

Public ContactYang Li

The First Affiliated Hospital of Zhengzhou University

ly_lily@163.com+86 13613718622

Outcome results

None listed

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