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The effect of nalbuphine on the prevention of emergence agitation in children undergoing tonsillectomy and adenoidectomy under general anesthesia

The effect of nalbuphine on the prevention of emergence agitation in children undergoing tonsillectomy and adenoidectomy under general anesthesia, a prospective, randomized, double-blind, controlled, multicenter study

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029340
Enrollment
Unknown
Registered
2020-01-25
Start date
2020-01-31
Completion date
Unknown
Last updated
2020-02-03

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

Conditions

Anesthesia for tonsillectomy in children

Interventions

group nalbuphine:nalbuphine iv 0.2 ml/kg
group control:saline iv

Sponsors

The First People's Hospital of Foshan
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 9 Years

Inclusion criteria

Inclusion criteria: (1) Adenoidectomy under general anesthesia in children aged 3-9 years; (2) ASA I-II; (3) Body mass index 18-23; (4) Children's families voluntarily participate in and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Known or suspected to be allergic or contraindicated to various components of the study drug or other opioid drugs; (2) Analgesic, sedative, antiemetic and anti pruritus drugs were used 24 hours before operation; (3) patient in shock or coma; (4) Patients with asthma or respiratory depression; (5) Brain injury, intracranial injury or existing intracranial hypertension; (6) Long term use of analgesics, psychoactive drugs (including opioids, NSAIDs, sedatives, antidepressants, etc.); alcohol abuse, drug abuse and addiction in patients with chronic pain; (7) Liver and kidney function: when ALT and / or ast exceeds 1.5 times of the upper limit of the medical reference value, the serum creatinine or urea nitrogen exceeds the normal value; (8) Severe arrhythmia, cardiac insufficiency (NYHA grade >= III), unstable angina pectoris, acute myocardial infarction within the past 6 months, patients who did not receive regular antihypertensive treatment or poor blood pressure control (SBP >= 160 mmHg and / or DBP >= 100 mmHg), or patients who (SBP <= 90 mmHg and / or DBP <= 60 mmHg); (9) Those who are unable to give full informed consent due to mental disorders and cannot express their wishes correctly; (10) A patient with a known history of neurological abnormalities, such as seizures; (11) Those who have received any other investigational drug within 3 months before inclusion; (12) The researcher judged that the subjects' compliance was not good and could not strictly implement the protocol.

Design outcomes

Primary

MeasureTime frame
PAED scores;pain intensity;

Secondary

MeasureTime frame
the time to eye opening;the time to extubation;Time for the body to return to conscious movement;time to recovery;incidence of nausea and vomiting;incidence of respiratory inhibition;satisfaction of medical staff,;satisfaction of guardians;time duration stay in PACU;

Countries

China

Contacts

Public ContactWang Hanbin

Department of Anesthesiology, the First People's Hospital of foshan

wanghanbing2@126.com+86 18038862186

Outcome results

None listed

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