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Safety and effectiveness study of removal of stitches for pediatric wound using EMLA cream

Safety and effectiveness study of removal of stitches for pediatric donor site of iliac bone using EMLA cream

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs031210247
Enrollment
10
Registered
2021-08-17
Start date
2021-12-25
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

unilateral cleft lip palate

Interventions

For children who have undergone cleft palate surgery, we will examine the safety and effectiveness of using EMLA cream when removing the postoperative iliac wound stitchces.

Sponsors

Aihara Yukiko
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients with unilateral cleft lip palate. 2) Patients performed cleft palate plasty using iliac bone graft. 3) Seven years old and over, under 13 years old. 4) Patients whose proxies ( parent or custody) got a sufficient explanation in participating in this study, with sufficient understanding, and wrote consent voluntarily. 5) Hospitalized patients.

Exclusion criteria

Exclusion criteria: 1) Patients with a history of allergies to lidocaine or propitocaine. 2) Complications such as hematoma, infection, and dehiscence in the postoperative surgical wound. 3) Patients who cannot express their intention on the subjective pain scale ( NRS: numeric rating scale) after removal of stitches. 4) Patients with history of surgery or trauma at the donor site. 5) Patients who cannot skip analgesics on the day of removal of stitches. 6) In addition, patients who are judged by the research-responsible doctor to be inappropriate as subjects.

Design outcomes

Primary

MeasureTime frame
Subjective pain (NRS: numeric rating scale)

Secondary

MeasureTime frame
Side effects of EMLA cream

Contacts

Public ContactMasahiro Sasaki

Tsukuba University Hospital

sasaki.masahiro.dw@ms.hosp.tsukuba.ac.jp+81-29-853-3122

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026