NCT05878262

The Effect of Pre-emptive Analgesia on the Postoperative Pain in Children Undergoing Pediatric Stomatology Day Surgeries

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: The Children's Hospital of Zhejiang University School of Medicine · Academic / Other
• Sex: All
• Age: 3 Years – 8 Years
• Healthy volunteers: Accepted

Summary

The aim of this double-blinded, randomized, controlled trial was to test whether pre-emptive analgesia with ibuprofen suppository is effective for children undergoing pediatric stomatology day surgeries in the postoperative period.

Detailed description

The recruited patients were randomly assigned into either the pre-emptive analgesia group or the control group. After the induction of anesthesia was performed, the nurse delivered the ibuprofen suppository at the dose of 5-10 mg/Kg for children of the pre-emptive analgesia group, and no measures were taken for the control group. All procedures of frenectomy, extraction of supernumerary teeth and excision of oral mucoceles were performed by a single surgeon. Postoperative pain was assessed using the Visual Analogue Scale (VAS), the Wong-Baker Faces Pain Rating Scale (WBS), and the Face, Leges, Activity, Cry, and Consolability (FLACC) scale, and Postoperative Parental Pain Assessment (PPPM) scale. The postoperative pain was measured 1, 4, and 24 hours after the surgery.

Conditions

• Ankyloglossia
• Oral Mucoceles
• Supernumerary Teeth

Interventions

Type	Name	Description
DRUG	ibuprofen suppository	After the induction of anesthesia was performed, the nurse delivered the ibuprofen suppository at the dose of 5-10 mg/Kg for the pre-emptive analgesia group children.

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-03-15
• Completion: 2023-05-01
• First posted: 2023-05-26
• Last updated: 2023-05-26

Locations

1 site across 1 country: China