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The application of hydromorphone in the treatment of agitation during the recovery period of general anesthesia in children

The application of hydromorphone in the treatment of agitation during the recovery period of general anesthesia in children

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091839
Enrollment
Unknown
Registered
2024-11-05
Start date
2024-11-05
Completion date
Unknown
Last updated
2024-11-11

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

Conditions

Emergence Agitation

Interventions

Administration during anesthesia induction group:Hydromorphone hydrochloride 0.01 mg/kg was given during anesthesia induction.
Administration before the end of surgery group:Hydromorphone hydrochloride 0.01 mg/kg was given 10 minutes before the end of the surgery.
NS group:Equal volumes of 0.9% sodium chloride injection were given
Fentanyl group:When the children were diagnosed with EA in the PACU, they were intravenously injected with0 .5 µg/kg fentanyl and 1 mg/kg propofol.
Hydromorphone group:When the patient was diagnosed with EA in the PACU , intravenous injection of 5 µg/kg hydromorphone and 1 mg/kg propofol was given.

Sponsors

Linyi People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: Part one: a. Age 3-7 years; b. Children undergoing elective tonsillectomy (or with adenoids) under seoflurane anesthesia; c. American Society of Anesthesiologists (ASA) class I-II. Part two: a. Children who developed emergence agitation tonsillectomy (and/or adenoids) surgery; b. Age 3-7 years; c. ASA class I-II.

Exclusion criteria

Exclusion criteria: First part: a. Patients with a history of heart and lung diseases; b. Patients with a history of neurological or psychiatric diseases; c.Those who are allergic to the drugs used; d. Those with liver and kidney dysfunction; e. Surgical procedures lasting more than 1 hour. Second part: a. Patients with a history of heart and lung diseases; b. Patients with a history of neurological or psychiatric diseases; c. Those who are allergic to the drugs used; d. Those with liver and kidney dysfunction.

Design outcomes

Primary

MeasureTime frame
PAED scale (Part One);PAED score (Part Two);The Recurrence Rate of Agitation (Part Two);The number of times propofol is added (Part Two);The total amount of propofol used (Part Two);

Secondary

MeasureTime frame
FLACC scale (Part One);Ramsay scale (Part One);heart rate, HR (Part One);mean arterial pressure, MAP (Part One);SPO2 (Part One);Total number of cases with additional propofol after surgery (Part One);Extubation time (Part One);Time of leaving PACU (Part One);FLACC Scale (Part Two);Ramsay Scale (Part Two);heart rate, HR (Part Two);SPO2 (Part Two);blood pressure, BP (Part Two);

Countries

China

Contacts

Public ContactXiming Li

Linyi People's Hospital

13515397176@163.com+86 135 1539 7176

Outcome results

None listed

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