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

NCT05878262 | Completed DMC

• 1 other identifier: 2022-IRB-183
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Ankyloglossia; Oral Mucoceles; Supernumerary Teeth

Keywords

pre-emptive analgesia; pediatric stomatology day surgeries; postoperative pain

Outcome Measures

Primary Outcomes (12)

• 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 "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.

  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 "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.

  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 "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.

  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

Study Arms (2)

pre-emptive analgesia group

EXPERIMENTAL

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

Drug: ibuprofen suppository

control group

NO INTERVENTION

No medicine was taken for the control group.

Interventions

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.

Also known as: no medicine

pre-emptive analgesia group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310057, China

Location

Related Publications (2)

• 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.

  PMID: 35628840 RESULT

• 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.

  PMID: 11744585 RESULT

MeSH Terms

Conditions

Ankyloglossia; Tooth, Supernumerary; Pain, Postoperative

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; Tooth Abnormalities; Stomatognathic System Abnormalities; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Fangqi Gong, doctor

  Medical Ethics Committee, Children's Hospital, Zhejiang University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: May 26, 2023
• Study Start: September 1, 2022
• Primary Completion: March 15, 2023
• Study Completion: May 1, 2023
• Last Updated: May 26, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data can be available now.
• Access Criteria: researchers who study the pre-emptive analgesia, and pediatric stomatologists

Locations

CN (1)