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Nalbuphine Hydrochloride Injection for pediatric postoperative analgesia multicenter clinical trial

Evaluation of Nalbuphine Hydrochloride Injection for pediatric postoperative analgesia Efficacy andsafety of randomized, double-blind, multicenter clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17012969
Enrollment
Unknown
Registered
2017-10-13
Start date
2015-10-26
Completion date
Unknown
Last updated
2017-10-16

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

Conditions

pain

Interventions

experimental group:Nalbuphine Hydrochloride

Sponsors

The 2nd Affiliated Hospital & Yuying Childrens Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 11 Years

Inclusion criteria

Inclusion criteria: 1. Aged 3-10 years male and female; 2. Body mass index (BMI) 24.5kg/m2=BMI=15.5kg/m2, and body weight above 12kg; 3. ASA anesthesia grade I-II; 4. Select the line of tonsil adenoidectomy in children (general anesthesia, non-complex local anesthesia); 5. Anesthesia operation time> 30min and <90min; 6. Children's parent or legal guardian sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Allergy to nalbupicin or its components, opioid allergy history children; 2. twenty four months before the use of analgesic sedatives, antiemetic drugs and anti-pruritus drugs; 3. twenty four hours before the body temperature higher than 38 degree C. or with acute upper respiratory tract infection symptoms of children; 4. Children with a history of bronchial asthma; 5. Preoperative diagnosis of severe sleep apnea syndrome in children; arrhythmia in children; 6. Preoperative assessment of difficult airway or previous abnormal history of anesthesia recovery; 7. Liver function damage (ALT and / or AST> 1.5 times the upper limit of normal reference) for renal dysfunction (BUN and / or Cr> normal reference) 8. 6 months with severe head trauma history, intracranial hypertension in children; 9. suffering from mental, neurological disease, and can not correctly express the wishes of children; 10. coagulation dysfunction (PT/TT higher than the upper limit of reference); 11. long-term sedative analgesic medication taking children; 12. Surgery time more than 1.5h or intraoperative additional anesthesia analgesics, sedative children; 13. Surgical blood loss greater than 100ml children; 14. Participated in other drug clinical trials in the past month; 15. Children who can not score FLACC for various reasons 16. Associated with other circumstances, the researchers think that is not suitable for selected children.

Design outcomes

Primary

MeasureTime frame
VAS scores;

Countries

China

Contacts

Public ContactLiu Huacheng

The 2nd Affiliated Hospital & Yuying Childrens Hospital of Wenzhou Medical University

huachengliu@163.com+86 13957770577

Outcome results

None listed

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