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

Zhejiang University logo

Zhejiang University

Status

Completed

Conditions

Oral Mucoceles
Ankyloglossia
Supernumerary Teeth

Treatments

Drug: ibuprofen suppository

Study type

Interventional

Funder types

Other

Identifiers

NCT05878262
2022-IRB-183

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

3 to 8 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

120 participants in 2 patient groups

pre-emptive analgesia group
Experimental group
Description:
For the pre-emptive analgesia group children, the nurse delivered the ibuprofen suppository at the dose of 5-10 mg/Kg.
Treatment:
Drug: ibuprofen suppository
control group
No Intervention group
Description:
No medicine was taken for the control group.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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