Ankyloglossia, Oral Mucoceles, Supernumerary Teeth
Conditions
Keywords
pre-emptive analgesia, pediatric stomatology day surgeries, postoperative pain
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.
Detailed 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.
Interventions
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.
Sponsors
The Children's Hospital of Zhejiang University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
The patients were randomly assigned into either the pre-emptive analgesia group or the control group
Eligibility
Sex/Gender
ALL
Age
3 Years to 8 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The VAS scores for postoperative 1 hour pain | 1 hour after surgery | The Visual Analogue Scale (VAS) is a line that is often 10 cm long with the markings 1to10,1indicates no pain, and10represents 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. |
| The WBS scores for postoperative 1 hour pain | 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. |
| The FLACC scores for postoperative 1 hour pain | 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. |
| The PPPM scores for postoperative 1 hour pain | 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. |
| The VAS scores for postoperative 4 hours pain | 4 hours after surgery | The Visual Analogue Scale (VAS) is a line that is often 10 cm long with the markings 1to10,1indicates no pain, and10represents 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. |
| The WBS scores for postoperative 4 hours pain | 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. |
| The FLACC scores for postoperative 4 hours pain | 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. |
| The PPPM scores for postoperative 4 hours pain | 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. |
| The VAS scores for postoperative 24 hours pain | 24 hours after surgery | The Visual Analogue Scale (VAS) is a line that is often 10 cm long with the markings 1to10,1indicates no pain, and10represents 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. |
| The WBS scores for postoperative 24 hours pain | 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. |
| The FLACC scores for postoperative 24 hours pain | 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. |
| The PPPM scores for postoperative 24 hours pain | 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. |
Countries
China
Outcome results
None listed