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Effect of alternating ibuprofen and diclofenac potassium suppositories on opioid analgesic use after funnel chest surgery in children: a randomized controlled trial

Effect of alternating ibuprofen and diclofenac potassium suppositories on opioid analgesic use after funnel chest surgery in children: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089927
Enrollment
Unknown
Registered
2024-09-19
Start date
2024-09-23
Completion date
Unknown
Last updated
2024-09-23

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

Conditions

Funnel chest

Interventions

Regular medication group (Group R):Group R: diclofenac potassium suppository 12.5mg-25mg anally at 8h and 32h postoperatively
ibuprofen 7.5mg/kg orally at 16h, 24h, 40h and 48h postoperatively (maximum 400mg/dose).
Drugs-on-demand group (Group D):Group D: Postoperative children with VAS score =4 or with verbal need to request ibuprofen 7.5 mg/kg (maximum 400 mg/dose) or diclofenac potassium suppositories 12.5 mg

Sponsors

Shanghai Children’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: (1) ASA class I-II (2) Age 12-18 years old

Exclusion criteria

Exclusion criteria: (1) Patients with a history of gastrointestinal bleeding or perforation following application of NSAIDs; (2) Patients who are allergic to ibuprofen or diclofenac sodium and those who have developed asthma, urticaria, or anaphylaxis after taking aspirin, COX-2 inhibitors, and other NSAIDs; (3) Patients with narcotic drug dependence or opioid tolerance prior to enrollment; (4) Combined serious cardiac, hepatic and renal abnormalities (5) Patients who have used anticoagulant or antiplatelet drugs such as warfarin and clopidogrel for a long period of time (more than three months) in the past;

Design outcomes

Primary

MeasureTime frame
Opioid consumption within 48 hours after surgery;

Secondary

MeasureTime frame
Number of compressions and dosage of intravenous analgesic pumps at 24 and 48 hours postoperatively;Incidence of moderate to severe pain (VAS pain score =4) at 4 postoperative time points (8h, 16h, 24h, 48h);Incidence of postoperative nausea and vomiting (PONV) within 48 hours of surgery;Use of additional analgesics and antiemetics;Use of additional analgesics and antiemetics;Days of hospitalization;Complications, including gastrointestinal bleeding, wound infection, hematoma, and nerve damage;

Countries

China

Contacts

Public ContactJiang Yan

Department of Anesthesiology, Shanghai Children’s Hospital

xilingxi@163.com+86 138 1623 7007

Outcome results

None listed

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