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Completed

NCT Number: NCT05878262

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

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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Key information

Conditions

Ankyloglossia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Neurologic Manifestations Oral Mucoceles Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Stomatognathic Diseases Stomatognathic System Abnormalities Supernumerary Teeth Tooth Abnormalities Tooth Diseases Tooth, Supernumerary

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310057, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ibuprofen suppository

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.

Other names: no medicine

Primary outcomes

  1. The VAS scores for postoperative 1 hour pain

    Time frame: 1 hour after surgery

    The Visual Analogue Scale (VAS) is a line that is often 10 cm long with the markings "1"to"10","1"indicates no pain, and"10"represents 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.

  2. The WBS scores for postoperative 1 hour pain

    Time frame: 1 hour after surgery

    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.

  3. The FLACC scores for postoperative 1 hour pain

    Time frame: 1 hour after surgery

    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.

  4. The PPPM scores for postoperative 1 hour pain

    Time frame: 1 hour after surgery

    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.

  5. The VAS scores for postoperative 4 hours pain

    Time frame: 4 hours after surgery

    The Visual Analogue Scale (VAS) is a line that is often 10 cm long with the markings "1"to"10","1"indicates no pain, and"10"represents 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.

  6. The WBS scores for postoperative 4 hours pain

    Time frame: 4 hours after surgery

    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.

  7. The FLACC scores for postoperative 4 hours pain

    Time frame: 4 hours after surgery

    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.

  8. The PPPM scores for postoperative 4 hours pain

    Time frame: 4 hours after surgery

    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.

  9. The VAS scores for postoperative 24 hours pain

    Time frame: 24 hours after surgery

    The Visual Analogue Scale (VAS) is a line that is often 10 cm long with the markings "1"to"10","1"indicates no pain, and"10"represents 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.

  10. The WBS scores for postoperative 24 hours pain

    Time frame: 24 hours after surgery

    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.

  11. The FLACC scores for postoperative 24 hours pain

    Time frame: 24 hours after surgery

    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.

  12. The PPPM scores for postoperative 24 hours pain

    Time frame: 24 hours after surgery

    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.

Sponsors and collaborators

Lead sponsor

The Children's Hospital of Zhejiang University School of Medicine

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 26, 2023
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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