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A randomized controlled clinical trial of ibuprofen injection for multimodal analgesia in children with cleft palate

A randomized controlled clinical trial of ibuprofen injection for multimodal analgesia in children with cleft palate

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043718
Enrollment
Unknown
Registered
2021-02-27
Start date
2021-02-15
Completion date
Unknown
Last updated
2021-06-28

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

Conditions

Cleft palate

Interventions

experimental group:Recieved ibuprofen injection
control group:Nil

Sponsors

Shanghai Children's Medical Center affiliated to Medical College of Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. The subjects of single cleft palate repair under general anesthesia; 2. Subjects older than 6 months; 3. ASA I-II subjects.

Exclusion criteria

Exclusion criteria: 1. Subjects allergic to ibuprofen injection and its components; 2. Subjects allergic to opioids; 3. Subjects with congenital hemorrhagic diseases; 4. Subjects with active bleeding; 5. Subjects with liver and kidney dysfunction; 6. Subjects with congenital brain dysfunction or heart disease; 7. Subjects who received NSAIDs, opioids, local anesthetics or other painkillers within 4 hours before operation.

Design outcomes

Primary

MeasureTime frame
opioids administration in PACU;

Countries

China

Contacts

Public ContactYing Sun

Shanghai Children's Medical Center affiliated to Medical College of Shanghai Jiaotong University

yingsun821@163.com+86 13621738118

Outcome results

None listed

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