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Comparison of different doses of esketamine combined with dexmedetomidine for sedation and analgesia during wound dressing changes in children with burns: a prospective, double-blind, randomized controlled study

Comparison of different doses of esketamine combined with dexmedetomidine for sedation and analgesia during wound dressing changes in children with burns: a prospective, double-blind, randomized controlled study

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101004
Enrollment
Unknown
Registered
2025-04-17
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

Burn(s),Burn pain,Procedural pain,Acute pain

Interventions

SKET-0.1 group:Dexmedetomidine continuous infusion at 60 mL/h + esketamine 0.1 mg/kg IV bolus
SKET-0.5 group:Dexmedetomidine continuous infusion at 60 mL/h + esketamine 0.5 mg/kg IV bolus
SKET-0.3 group:Dexmedetomidine continuous infusion at 60 mL/h + esketamine 0.3 mg/kg IV bolus

Sponsors

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 6 Years

Inclusion criteria

Inclusion criteria: 1.The burn surgery department plans to perform wound dressing change for the pediatric burn patient. 2.Children aged 1–6 years (both sexes eligible). 3.BMI >= -3 SD and < +3 SD; 4.Burn severity: Mild to severe, defined as total burn area = 25% TBSA (Total Body Surface Area) or third-degree burns <= 10% TBSA. 5.No significant underlying diseases, with ASA (American Society of Anesthesiologists) Physical Status Classification of I-II. 6.The parents or legal guardians are fully informed and have consented to participate in the entire research process.

Exclusion criteria

Exclusion criteria: 1.Pediatric patients currently on sedative medication; 2.Children with a history of asthma; 3.Patients with third-degree (full-thickness) burns involving the head and face; 4.Pediatric patients with extensive burns complicated by severe infection/shock, or those currently presenting with upper respiratory tract infections; 5.Pediatric patients with inhalation lung injury requiring mechanical ventilation or tracheostomy; 6.Pediatric patients with hypersensitivity to any investigational drug(s); 7.Pediatric patients with severe organ dysfunction (e.g., heart failure/severe hepatic or renal insufficiency) and unstable vital signs; 8.Parents or legal guardians of the pediatric patient declined to provide informed consent;

Design outcomes

Primary

MeasureTime frame
Face, Legs, Activity, Cry, Consolability Scale;

Secondary

MeasureTime frame
Time to achieve medium-depth sedation after esketamine administration;vital signs;UMSS scale;Cry,Facial,Child Verbal,Torso,Touch,Legs Scale;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactSong Xiaoxing

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

sxx11493@rjh.com.cn+86 136 3637 8736

Outcome results

None listed

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