Clinical trial NCT05878262: The Effect of Pre-emptive Analgesia on the Postoperative Pain in Children Undergoing Pediatric Stomatology Day Surgeries
Official title: The Effect of Pre-emptive Analgesia on the Postoperative Pain in Children Undergoing Pediatric Stomatology Day Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankyloglossia
Oral Mucoceles
Supernumerary Teeth
Keywords: pre-emptive analgesia
pediatric stomatology day surgeries
postoperative pain
Lead sponsor: The Children's Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 120
Sex: ALL
Minimum age (years): 3
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients were randomly assigned into either the pre-emptive analgesia group or the control group
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* an age of 3-8 years; undergoing upper labial frenectomy, lingual frenectomy, extraction of supernumerary teeth, excision of oral mucoceles and the written informed consent from the parents or guardians.

Exclusion Criteria:

* children or parents refusal for study participation; intellectual disability, major systemic diseases; allergy to ibuprofen and other medications used in the study protocol.

Primary outcomes:
measure: The VAS scores for postoperative 1 hour pain
timeFrame: 1 hour after surgery
measure: The WBS scores for postoperative 1 hour pain
timeFrame: 1 hour after surgery
measure: The FLACC scores for postoperative 1 hour pain
timeFrame: 1 hour after surgery
measure: The PPPM scores for postoperative 1 hour pain
timeFrame: 1 hour after surgery
measure: The VAS scores for postoperative 4 hours pain
timeFrame: 4 hours after surgery
measure: The WBS scores for postoperative 4 hours pain
timeFrame: 4 hours after surgery
measure: The FLACC scores for postoperative 4 hours pain
timeFrame: 4 hours after surgery
measure: The PPPM scores for postoperative 4 hours pain
timeFrame: 4 hours after surgery
measure: The VAS scores for postoperative 24 hours pain
timeFrame: 24 hours after surgery
measure: The WBS scores for postoperative 24 hours pain
timeFrame: 24 hours after surgery
measure: The FLACC scores for postoperative 24 hours pain
timeFrame: 24 hours after surgery
measure: The PPPM scores for postoperative 24 hours pain
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Children's Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Medical Ethics Committee, Children's Hospital, Zhejiang University School of Medicine
name: Fangqi Gong, doctor
role: STUDY_CHAIR
References:
citation: Zielinski J, Morawska-Kochman M, Dudek K, Czapla M, Zatonski T. The Effect of Pre-Emptive Analgesia on the Postoperative Pain in Pediatric Otolaryngology: A Randomized, Controlled Trial. J Clin Med. 2022 May 11;11(10):2713. doi: 10.3390/jcm11102713.
citation: Kelly DJ, Ahmad M, Brull SJ. Preemptive analgesia II: recent advances and current trends. Can J Anaesth. 2001 Dec;48(11):1091-101. doi: 10.1007/BF03020375.