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Clinical observation of nalbuphine for the prevention of agitation after postoperative penile orthopedics in children

Clinical observation of nalbuphine for the prevention of agitation after postoperative penile orthopedics in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095513
Enrollment
Unknown
Registered
2025-01-08
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Occult penis in children

Interventions

Sponsors

Foshan Women and Children Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Children aged 2-12 years who choose to undergo elective penile orthopedics in our hospital (2) ASA is graded in I-II (3) Normal development, BMI index between 18.5 kg/m2 and 30 kg/m2 (4) Sign the informed consent form;

Exclusion criteria

Exclusion criteria: (1) Premature infants, abnormal stunting (2) Epilepsy, altered mental status, and abnormal neurological function (3) Heart, liver and kidney dysfunction, moderate to severe anemia, craniocerebral disease and increased intracranial pressure (4) hypersensitivity to nalbuphine or other medications used in this study (5) Give sedative, analgesic, antiemetic or antipruritic drugs 24 hours before surgery (6) Receiving other experimental drug treatment within 3 months.

Design outcomes

Primary

MeasureTime frame
Restlessness Assessment Scale for Awakening (Pader) score;

Secondary

MeasureTime frame
Awakening time, PACU stay time, laryngospasm, number of nausea and vomiting cases;Postoperative pain scores in children (FLACC) ;Hemodynamic indicators;

Countries

China

Contacts

Public ContactShi Wenjun

Foshan Women and Children Hospital

75824521@qq.com+86 18038831042

Outcome results

None listed

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