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The Effect of Nalbuphine on Emergence Agitation in Preschool Children Undergoing Otolaryngologic Surgery: A Randomized Controlled Clinical Study

The Effect of Nalbuphine on Emergence Agitation in Preschool Children Undergoing Otolaryngologic Surgery: A Randomized Controlled Clinical Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114207
Enrollment
Unknown
Registered
2025-12-09
Start date
2025-12-09
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Emergence agitation

Interventions

Nalbuphine Group:A dose of 0.1 mg/kg nalbuphine was administered intravenously 15 to 30 minutes before the end of surgery.
Control Group:An equal volume of normal saline was administered intravenously 15 to 30 minutes before the end of surgery.

Sponsors

SUN YAT-SEN MEMORIAL HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1.ASA physical status I or II; 2.Scheduled to undergo otolaryngologic surgery; 3.Aged 3 to 7 years;

Exclusion criteria

Exclusion criteria: 1.Patients with attention deficit or hyperactivity disorder; 2.Autism; 3.Neurological disorders; 4.Pre-existing airway abnormalities or reactive airway disease; 5.History of psychotropic medication use or substance abuse within one month prior to surgery; 6.Major organ comorbidity; 7.Intellectual disability or developmental delay; 8.Genetic disorders; 9.Known allergy to nalbuphine;

Design outcomes

Primary

MeasureTime frame
Pediatric Anesthesia Emergence Delirium Score;

Secondary

MeasureTime frame
PACU Length of Stay;Medications used during the PACU stay;Heart rate, oxygen saturation, and blood pressure in the PACU;Postoperative Behavioral Changes;Adverse Events;Extubation Time;Face, Legs, Activity, Cry, Consolability Scale;Emergence Time;

Countries

China

Contacts

Public ContactGanglan Fu

SUN YAT-SEN MEMORIAL HOSPITAL

ganglan@126.com+86 20 81332060

Outcome results

None listed

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