Clinical trial
The Effect of Pre-emptive Analgesia on the Postoperative Pain in Children Undergoing Pediatric Stomatology Day Surgeries
Name
2022-IRB-183
Description
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.
Trial arms
Trial start
2022-09-01
Estimated PCD
2023-03-15
Trial end
2023-05-01
Status
Completed
Treatment
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.
Arms:
pre-emptive analgesia group
Other names:
no medicine
Size
120
Primary endpoint
The VAS scores for postoperative 1 hour pain
1 hour after surgery
The WBS scores for postoperative 1 hour pain
1 hour after surgery
The FLACC scores for postoperative 1 hour pain
1 hour after surgery
The PPPM scores for postoperative 1 hour pain
1 hour after surgery
The VAS scores for postoperative 4 hours pain
4 hours after surgery
The WBS scores for postoperative 4 hours pain
4 hours after surgery
The FLACC scores for postoperative 4 hours pain
4 hours after surgery
The PPPM scores for postoperative 4 hours pain
4 hours after surgery
The VAS scores for postoperative 24 hours pain
24 hours after surgery
The WBS scores for postoperative 24 hours pain
24 hours after surgery
The FLACC scores for postoperative 24 hours pain
24 hours after surgery
The PPPM scores for postoperative 24 hours pain
24 hours after surgery
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients were randomly assigned into either the pre-emptive analgesia group or the control group', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': '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.', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ACTUAL'}}
Updated at
2023-05-26
1 organization
1 product
3 indications
Product
IbuprofenIndication
AnkyloglossiaIndication
Mouth CystsIndication
Hyperdontia