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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| control group | No Intervention | No medicine was taken for the control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 "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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fangqi Gong, doctor | Medical Ethics Committee, Children's Hospital, Zhejiang University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | 310057 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35628840 | Result | 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. | |
| 11744585 | 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. |
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After the raw research data are collected and collated, we will make the data including study protocol, statistical analysis plan, informed consent form, clinical study report, and analytic code freely available to all researchers.
The data can be available now.
researchers who study the pre-emptive analgesia, and pediatric stomatologists
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The patients were randomly assigned into either the pre-emptive analgesia group or the control group
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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.
|
| 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 |
| ID | Term |
|---|---|
| D000072676 | Ankyloglossia |
| D014096 | Tooth, Supernumerary |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
| D014071 | Tooth Abnormalities |
| D018640 | Stomatognathic System Abnormalities |
| D014076 | Tooth Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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