Ankyloglossia Clinical Trial
Official title:
The Effect of Pre-emptive Analgesia on the Postoperative Pain in Children Undergoing Pediatric Stomatology Day Surgeries
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 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Children's Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
The Children's Hospital of Zhejiang University School of Medicine |
China,
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
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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