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A randomized controlled clinical trial comparing hydromorphone with fentanyl to improve postoperative pain and agitation in children after strabismus surgery

A randomized controlled clinical trial comparing hydromorphone with fentanyl to improve postoperative pain and agitation in children after strabismus surgery

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039555
Enrollment
Unknown
Registered
2020-10-31
Start date
2020-11-10
Completion date
Unknown
Last updated
2022-05-23

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

Conditions

postoperative pain management in children after strabismus surgery

Interventions

experimental group:Hydromorphone was intravenously pumped 0.02mg/kg (diluted to 10mL) and finished within 5min
control group:Fentanyl was intravenously pumped 3µg/kg (diluted to 10mL) and finished within 5min

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1.Children aged 3-7 years who planned to perform elective strabismus surgery. 2.The child was evaluated as an American Society of Anesthesiologists Physical Status 1 or 2. 3.The legal guardian of the child participated voluntarily and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Children who were allergic to fentanyl or hydromorphone. 2.Children with psychological or neurological disorders. 3.Children with hepatic or renal insufficiency 4.Refusing to cooperate or anesthesiologist who responsible for the subject refuse to participate. 5.The surgeon planned to perform local nerve block anesthesia before surgery. 6.Patients with an M-YPAS score of more than 60 points in the surgical waiting area or with crying before anesthesia induction

Design outcomes

Primary

MeasureTime frame
the Faces, Legs, Activity, Cry and Consolability (FLACC) Score;

Secondary

MeasureTime frame
PEAD score;Ramsay sedation score;vital signs of Intraoperative, and in PACU (oxygen saturation,heart rate, blood pressure);The time to pull out the endotracheal tube;Residence time of PACU;Duration of operation and anesthesia;The types and total amount of analgesic drugs used before discharge;the incidence of postoperative adverse events (respiratory depression, oversedation, nausea and vomiting, constipation, urinary retention, pruritus).;

Countries

China

Contacts

Public ContactChenguo

Department of Anesthesiology, West China Hospital, Sichuan University

894397461@qq.com+86 18980601577

Outcome results

None listed

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