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The effect of intranasal Dexmedetomidine combine with Ketorolac tromethamine for postoperative analgesia in children with tonsillectomy and /or adenoidectomy

The effect of intranasal Dexmedetomidine combine with Ketorolac tromethamine for postoperative analgesia in children with tonsillectomy and /or adenoidectomy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026900
Enrollment
Unknown
Registered
2019-10-26
Start date
2019-10-21
Completion date
Unknown
Last updated
2019-12-16

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

Conditions

The tonsils and/or adenoidal hypertrophy in children

Interventions

experimental group:intranasal Dexmedetomidine 1ug/kg (1ml)+Ketorolac tromethamine 0.5mg/kg iv before the surgery
control group:intranasal normal saline 1ml+ Ketorolac tromethamine 0.5mg/kg iv before surgery

Sponsors

The Second Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. The 3-7 years' children with tonsillectomy and /or adenoidectomy; 2. The grade of ASA is I-II; 3. The family members have signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. The children with congenital diseases; 2. The children with heard diseases and neuropsychosis; 3. The children with the abnormal function of endocrine, liver and kidney; 4. The children who are allergic to research drugs and have a history of asthma; 5. The children who have taken sedatives and analgesics for nearly a month; 6. The children who have been enrolled in other clinical trials.

Design outcomes

Primary

MeasureTime frame
pain score of FLACC;

Secondary

MeasureTime frame
The amount of remedial medicine (ibuprofen);The pain score of VRS;The sedation score of Ramsay;The concentration of NE and IL-6 in plasma;

Countries

China

Contacts

Public ContactPengbo Zhang

The Second Affiliated Hospital of Xi'an Jiaotong University

zhpbo@163.com+86 13759891076

Outcome results

None listed

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