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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-05-01

Brief Summary

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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.

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Detailed Description

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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

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Ankyloglossia Oral Mucoceles Supernumerary Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The patients were randomly assigned into either the pre-emptive analgesia group or the control group

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The patient, parents, surgeon and pain assessor were all blinded to the study. Only investigator, anesthetist and the nurse delivering the analgesic to the child were not blinded.

Study Groups

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pre-emptive analgesia group

For the pre-emptive analgesia group children, the nurse delivered the ibuprofen suppository at the dose of 5-10 mg/Kg.

Group Type EXPERIMENTAL

ibuprofen suppository

Intervention Type DRUG

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.

control group

No medicine was taken for the control group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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no medicine

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes