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Efficacy and safety of intravenous ibuprofenin the anesthetic induction period of pediatric tonsillectomy: a prospective, randomized, double-blind placebo-controlled clinical trial

Efficacy and safety of intravenous ibuprofen in the anesthetic induction period of pediatric tonsillectomy with/without adenoidectomy: a prospective, randomized, double-blind placebo-controlled clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044508
Enrollment
Unknown
Registered
2021-03-23
Start date
2021-04-01
Completion date
Unknown
Last updated
2021-09-20

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

Conditions

Tonsil hypertrophy with/without Adenoidal hypertrophy

Interventions

IV-Ibuprofen:a single dose of intravenous ibuprofen is administered in the anesthetic induction period
control group:normal saline

Sponsors

Beijing Children's Hospital, Capital Medical University, National Center for Children's Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age: 6 months to 8 years old; 2. ASA I - III; 3. scheduled tonsillectomy with/without adenoidectomy in our hospital; 4. Voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients use Analgesic drugs such as ibuprofen and tramadol within 24 hours before surgery; 2. Allergic to the main ingredients/excipients of intravenous ibuprofen; 3. Consciousness disorders/cognitive disorders; 4. Severe myocardial ischemia, heart failure and other cardiovascular disease; 5. Gastrointestinal bleeding, ulcer and perforation within 6 weeks before surgery; 6. Dehydration and abnormal kidney function; 7. ALT and AST increased by 2 times the normal upper limit; 8. Aspirin sensitive asthma; 9. Severe obstructive sleep apnea (OAHI> 10 times /h); 10. Patients with high bleeding risk; 11. Preoperative examination found patients with abnormal coagulation function.

Design outcomes

Primary

MeasureTime frame
number (%) of patients who received rescue fentanyl in the PACU;

Countries

China

Contacts

Public ContactCui Xiaohuan

Beijing Children's Hospital Affiliated to Capital Medical University

cui_xiaohuan@yeah.net+86 18811426656

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026