A randomized controlled study of intraoperative pumping hydromorphone to improve postoperative pain after tonsillectomy in children

A randomized controlled clinical trial comparing intraoperative constant speed pumping of hydromorphone with fentanyl for the improvement of pain after tonsillectomy in children

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000039914

Enrollment

Unknown

Registered

2020-11-14

Start date

2020-11-12

Completion date

Unknown

Last updated

2021-02-22

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

Conditions

Pain after tonsillectomy in children

Interventions

Fentanyl group (F group):Intravenous constant speed pump fentanyl 4ug/kg, pumping time 20min

Hydromorphone group (H group):Intravenous constant speed pump hydromorphone 40ug/kg, pumping time 20min

Eligibility

Sex/Gender

All

Age

3 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Children aged 3-7 years who are planning to undergo tonsillectomy; 2. American Society of Anesthesiologists classification (ASA) I-II; 3. The legal guardian of the child voluntarily participated and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects allergic to fentanyl and hydromorphone; 2. Patients with psychological or nervous system disorders; 3. Subjects with liver dysfunction; 4. Subjects with renal insufficiency; 5. Subjects who can't cooperate with the study for any reason, or those who are considered unsuitable by the anesthesiologist.

Design outcomes

Primary

Measure	Time frame
Flacc pain scale;	—

Secondary

Measure	Time frame
PAED score;Ramsay sedation score;Vital signs (SPO2, heart rate, NIBP) of PACU and 6h postoperative ward;The time to pull out the endotracheal tube;Time the child is awake;Duration of operation and anesthesia;The time of the first use of analgesic drugs after operation and the types and total amount of analgesic drugs;Number of postoperative adverse events (respiratory depression, oversedation, nausea and vomiting, constipation, urinary retention, pruritus);	—

Measure

Time frame

PAED score;Ramsay sedation score;Vital signs (SPO2, heart rate, NIBP) of PACU and 6h postoperative ward;The time to pull out the endotracheal tube;Time the child is awake;Duration of operation and anesthesia;The time of the first use of analgesic drugs after operation and the types and total amount of analgesic drugs;Number of postoperative adverse events (respiratory depression, oversedation, nausea and vomiting, constipation, urinary retention, pruritus);

—

Countries

China

Contacts

Public ContactGuo Chen

Department of Anesthesiology, West China Hospital of Sichuan University

grace_chenguo@hotmail.com+86 18980601577

Outcome results

None listed

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