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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05878262
Other study ID # 2022-IRB-183
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date May 1, 2023

Study information

Verified date May 2023
Source The Children's Hospital of Zhejiang University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date May 1, 2023
Est. primary completion date March 15, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 8 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
China Children's Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang

Sponsors (1)

Lead Sponsor Collaborator
The Children's Hospital of Zhejiang University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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