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A Study on the Efficacy and Safety of Tegileridine for Postoperative Analgesia in Children Undergoing Tonsillectomy

A Study on the Efficacy and Safety of Tegileridine for Postoperative Analgesia in Children Undergoing Tonsillectomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104086
Enrollment
Unknown
Registered
2025-06-10
Start date
2025-08-15
Completion date
Unknown
Last updated
2025-06-16

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

Conditions

Children Undergoing Tonsillectomy

Interventions

Tegileridine 0.005 mg/kg group:Intravenous injection of Tegileridine 0.005 mg/kg + normal saline up to 5 ml
Tegileridine 0.01 mg/kg group:Intravenous injection of Tegileridine 0.01 mg/kg + normal saline up to 5 ml
Tegileridine 0.015 mg/kg group:Intravenous injection of Tegileridine 0.015 mg/kg + normal saline up to 5 ml
placebo group:Inject 5 ml of normal saline intravenously.

Sponsors

The Second Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Children and adolescents aged 5-12 years undergoing elective pediatric tonsillectomy +/- adenoidectomy; (2) ASA I-II; (3) families willing to participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Individuals with autism and developmental delays, or cognitive impairments; (2) Those with a history of severe heart, brain, lung, liver, or kidney diseases; (3) Preoperative electrolyte imbalance, preoperative analgesic treatment, or a history of allergies to surgical procedures or study drugs; (4) History of neuromuscular system diseases or mental illnesses; (5) With a history of respiratory or cardiac diseases; (6) Presence of bleeding risk; (7) Family members unwilling to cooperate or refuse to participate.

Design outcomes

Primary

MeasureTime frame
Patient visual analogue score (VAS);

Secondary

MeasureTime frame
The number and frequency of patients receiving fentanyl rescue analgesia during the recovery period;Vital signs at each observation time - point: heart rate, non - invasive blood pressure, respiratory rate, pulse oxygen saturation;Extubation time;Duration of stay in PACU;Cumulative opioid consumption within 0 - 24 hours after administration of the investigational drug;PAED;Document various adverse reactions occurring in pediatric patients;Pediatric Patient and Family Satisfaction Score;

Countries

China

Contacts

Public ContactYingbin Wang

The Second Hospital of Lanzhou University

wangyingbin6@163.com+86 138 9313 3264

Outcome results

None listed

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