NIPH Clinical Trials Search

JRCT ID: jRCTs031210247

Registered date:17/08/2021

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

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedunilateral cleft lip palate
Date of first enrollment25/12/2021
Target sample size10
Countries of recruitment
Study typeInterventional
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.


Primary OutcomeSubjective pain (NRS: numeric rating scale)
Secondary OutcomeSide effects of EMLA cream

Key inclusion & exclusion criteria

Age minimum>= 7age old
Age maximum< 13age old
Include criteria1) 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 criteria1) 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


Public contact
Name Masahiro Sasaki
Address 2-1-1, Amakubo, Tsukuba city, Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3122
Affiliation Tsukuba University Hospital
Scientific contact
Name Yukiko Aihara
Address 2-1-1, Amakubo, Tsukuba city, Ibaraki Ibaraki Japan 305-8576
Telephone +81-29-853-3122
Affiliation University of Tsukuba Hospital