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

JRCT ID: jRCTs031210247

Registered date:17/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: unilateral cleft lip palate
• Date of first enrollment: 25/12/2021
• Target sample size: 10
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Subjective pain (NRS: numeric rating scale)
• Secondary Outcome: Side effects of EMLA cream

Key inclusion & exclusion criteria

• Age minimum: >= 7age old
• Age maximum: < 13age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Aihara Yukiko