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Efficacy and safety of esketamine for postoperative analgesia in children with hypospadias: A prospective, randomized, controlled, and double-blind clinical trial

Efficacy and safety of esketamine for postoperative analgesia in children with hypospadias: A prospective, randomized, controlled, and double-blind clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066967
Enrollment
Unknown
Registered
2022-12-22
Start date
2022-01-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

pain

Interventions

Estella ketamine group:300 g/kg/h estelline ketamine
Sufentanil group:20ug/kg/h hydromorphone

Sponsors

Guangzhou Women and Children’s Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
0.5 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1) Age: 6m ~ 6y, male; 2) children that will be performed tracheal intubation general anesthesia, ASA class ? ~ ? anesthesia; 3) Hypospadias surgery is planned under general anesthesia

Exclusion criteria

Exclusion criteria: 1) contraindications to sacral block, including sacral malformation and abnormal coagulation function; 2) preoperative signs of difficult airway; 3) enlarged tonsils, adenoidal hypertrophy, or arrhythmia; 4) hepatitis and/or renal dysfunction; 5) increased intracranial pressure and/or intracerebral hemorrhage; 6) pheochromocytoma and/or primary hyperaldosteronism; 7) severe cardiovascular disease; 8) glaucoma; 9) hyperthyroidism; 10) mental and neurological disease; 11) history of complications in post-anesthesia recovery and/or to analgesic use; 12) allergic reactions to esketamine, flurbiprofen axetil, opioids, or their components.

Design outcomes

Primary

MeasureTime frame
Face Legs Activity Crying Consolability Scores;Ramsay sedation score;

Countries

China

Contacts

Public ContactXingrong Song

Guangzhou Women and Children’s Medical Center

songxingrong510623@163.ocm86+02038076243

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026