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

Study Overview
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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.

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.

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

Conditions
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Ankyloglossia, Oral Mucoceles, Supernumerary Teeth

Intervention / Treatment
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* Drug: ibuprofen suppository


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The patients were randomly assigned into either the pre-emptive analgesia group or the control group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pre-emptive analgesia group<br>For the pre-emptive analgesia group children, the nurse delivered the ibuprofen suppository at the dose of 5-10 mg/Kg. | Drug: ibuprofen suppository<br>* 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.<br>* Other names: no medicine;|
| No Intervention: control group<br>No medicine was taken for the control group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The VAS scores for postoperative 1 hour pain | The Visual Analogue Scale (VAS) is a line that is often 10 cm long with the markings 1to10,1indicates no pain, and10represents very strong pain. The children were asked to mark a line on the scale to express the intensity of their pain at 1 hour postoperatively. | 1 hour after surgery | 
| The WBS scores for postoperative 1 hour pain | The Wong-Baker Faces Pain Rating Scale (WBS) contains six of faces from 0 point happy face representing no pain to 10 points crying face suggesting the strong pain. The children were asked to choose one face that indicating their state feelings at 1 hour postoperatively. | 1 hour after surgery | 
| The FLACC scores for postoperative 1 hour pain | The Face, Leges, Activity, Cry, and Consolability (FLACC) scale is an assessment tool that has five categories: facial expression, legs, activity, cry, and consolability. Each parameter is evaluated on a scale from 0 to 2, the total score is from 0-10 points. The FLACC scale was used by the researcher to assess pain at 1 hour after surgery. | 1 hour after surgery | 
| The PPPM scores for postoperative 1 hour pain | The Postoperative Parental Pain Assessment (PPPM) scale was is a valid and useful tool assessed by the parent or guardian for postoperative assessment of discharged children's pain. It has 15 items about children's emotional state, changes in appetite (eat less than usual , refuse to eat), behaviors, and activities, the total score is from 0-15 points. The PPPM scale was used by the parent or guardian to assess pain at 1 hour after surgery. | 1 hour after surgery | 
| The VAS scores for postoperative 4 hours pain | The Visual Analogue Scale (VAS) is a line that is often 10 cm long with the markings 1to10,1indicates no pain, and10represents very strong pain. The children were asked to mark a line on the scale to express the intensity of their pain at 4 hours postoperatively. | 4 hours after surgery | 
| The WBS scores for postoperative 4 hours pain | The Wong-Baker Faces Pain Rating Scale (WBS) contains six of faces from 0 point happy face representing no pain to 10 points crying face suggesting the strong pain. The children were asked to choose one face that indicating their state feelings at 4 hours postoperatively. | 4 hours after surgery | 
| The FLACC scores for postoperative 4 hours pain | The Face, Leges, Activity, Cry, and Consolability (FLACC) scale is an assessment tool that has five categories: facial expression, legs, activity, cry, and consolability. Each parameter is evaluated on a scale from 0 to 2, the total score is from 0-10 points. The FLACC scale was used by the researcher to assess pain at 4 hours after surgery. | 4 hours after surgery | 
| The PPPM scores for postoperative 4 hours pain | The Postoperative Parental Pain Assessment (PPPM) scale was is a valid and useful tool assessed by the parent or guardian for postoperative assessment of discharged children's pain. It has 15 items about children's emotional state, changes in appetite (eat less than usual , refuse to eat), behaviors, and activities, the total score is from 0-15 points. The PPPM scale was used by the parent or guardian to assess pain at 4 hours after surgery. | 4 hours after surgery | 
| The VAS scores for postoperative 24 hours pain | The Visual Analogue Scale (VAS) is a line that is often 10 cm long with the markings 1to10,1indicates no pain, and10represents very strong pain. The children were asked to mark a line on the scale to express the intensity of their pain at 24 hours postoperatively. | 24 hours after surgery | 
| The WBS scores for postoperative 24 hours pain | The Wong-Baker Faces Pain Rating Scale (WBS) contains six of faces from 0 point happy face representing no pain to 10 points crying face suggesting the strong pain. The children were asked to choose one face that indicating their state feelings at 24 hours postoperatively. | 24 hours after surgery | 
| The FLACC scores for postoperative 24 hours pain | The Face, Leges, Activity, Cry, and Consolability (FLACC) scale is an assessment tool that has five categories: facial expression, legs, activity, cry, and consolability. Each parameter is evaluated on a scale from 0 to 2, the total score is from 0-10 points. The FLACC scale was used by the researcher to assess pain at 24 hours after surgery. | 24 hours after surgery | 
| The PPPM scores for postoperative 24 hours pain | The Postoperative Parental Pain Assessment (PPPM) scale was is a valid and useful tool assessed by the parent or guardian for postoperative assessment of discharged children's pain. It has 15 items about children's emotional state, changes in appetite (eat less than usual , refuse to eat), behaviors, and activities, the total score is from 0-15 points. The PPPM scale was used by the parent or guardian to assess pain at 24 hours after surgery. | 24 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pre-emptive analgesia, pediatric stomatology day surgeries, postoperative pain