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The effect of a single injection of nalbuphine and dexmedetomidine on postoperative pain after adenoid tonsillectomy in children

The effect of a single injection of nalbuphine and dexmedetomidine on postoperative pain after adenoid tonsillectomy in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098449
Enrollment
Unknown
Registered
2025-03-07
Start date
2025-03-11
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

obstructive sleep apnea-hypopnea syndrome

Interventions

Dexmedetomidine (D) group:Dexmedetomidine 0.2 ml/kg (diluted to 2.5ug/ml dexmedetomidine) administered intravenously at induction of anesthesia
Nalbuphine (N) group:0.2 ml/kg of nalbuphine (diluted to 1.5 mg/ml nalbuphine) administered sedately at induction of anesthesia

Sponsors

Shanghai Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1) ASA Level I-II ; 2) Age 3-12 years ; ;3) Body mass index (BMI) >=15.5 kg/m^2 and <=24.5 kg/m^2 with weight over 12 kg;

Exclusion criteria

Exclusion criteria: 1) Hypersensitivity to the drugs used in this study or opioid abuse; 2) Severe obstructive sleep apnea syndrome and cardiac arrhythmia; 3) Combined serious cardiac, hepatic, renal dysfunction and mental abnormality; 4) Fever higher than 38°C or acute upper respiratory tract infection and bronchial asthma in the 24 hours before surgery.

Design outcomes

Primary

MeasureTime frame
Incidence of moderate to severe pain on swallowing within 4 hours after surgery;

Secondary

MeasureTime frame
FLACC score (3-6 years) or NRS score (7-12 years) at rest and during swallowing at 0h, 0.5h, 2h, and 4h postoperatively;Incidence of postoperative adverse reactions;Number of children requiring additional postoperative analgesia;Incidence of agitation while in the PACU in both groups of children;

Countries

China

Contacts

Public ContactHongyun Li

Shanghai Children's Hospital

lihyshchildren@126.com+86 15216696807

Outcome results

None listed

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