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The efficacy and safety of nalbuphine hydrochloride injection for perioperative analgesia in pediatric laparoscopic surgery: A multicenter, randomized, double-blind, parallel, active control clinical study

The efficacy and safety of nalbuphine hydrochloride injection for perioperative analgesia in pediatric laparoscopic surgery: A multicenter, randomized, double-blind, parallel, active control clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024202
Enrollment
Unknown
Registered
2019-06-30
Start date
2019-07-10
Completion date
Unknown
Last updated
2019-07-01

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

Conditions

Children disease

Interventions

experimental group :Nalbuphine injection
control group:Morphine injection

Sponsors

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical Universtiy
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 1-7 years; 2. ASA I-II; 3. laparoscopic surgery; 4. Operation time less than 120 min; 5. Informed consent form signed by the parent or legal guardian.

Exclusion criteria

Exclusion criteria: 1. BMI>=28kg/m2 or = 28kg; 2. Be allergic to nalbuphine, its components and opioid medicine; 3 Preoperative using analgesic, sedatives, antiemetics or antipruritics in 24 h; 4. Preoperative body temperature was higher than 38 degree C or suffering from upper respiratory infection in 24h; 5. Suffered from bronchial asthma; 6. Suffering from severe obstructive sleep apnea syndrome and arrhythmia; 7. Having difficult airway. had abnormal surgery or anesthesia recovery. 8. BUN or CR > upper limitation of normal value; ALT or AST > upper limitation of normal value. 9. Suffered from severe traumatic brain injury in 6 month. intracranial hypertension. 10. Suffering from mental disease or cant express their mind exactly. 11. Sedatives or analgesics administration for a long time. 12. The blood loss >100 ml. 13. Participated another clinical trial of medicine in a month. 14. Score of FLACC cant accomplished with various reasons. 15. With other conditions, the investigator believe that it is not suitable for the trial.

Design outcomes

Primary

MeasureTime frame
Number of children requiring rescue analgesia in PACU;

Secondary

MeasureTime frame
Number of children requiring rescue analgesia during operation;Heart rate and blood pressure;The removal time of laryngeal mask airway;Awaken time;FLACC pain score;Ramsay sedation score;Extra analgesia in PACU;Retention time in PACU;Anesthesia satisfaction score;

Countries

China

Contacts

Public ContactHuacheng Liu

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical Universtiy

huachengliu@163.com+86 13957770577

Outcome results

None listed

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