Clinical trial
Effect of Systematic Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
Name
8/2023
Description
Effect of systematic dexamethasone on the duration of popliteal nerve block after pediatric ankle/foot surgery
Trial arms
Trial start
2023-10-17
Estimated PCD
2024-02-23
Trial end
2024-02-23
Status
Completed
Phase
Early phase I
Treatment
Sodium Chloride 0.9% Inj
administration of 5ml 0,9% sodium chloride - 30 minutes before the popliteal nerve block
Arms:
placebo injection
Other names:
Placebo
0,1mg/kg Dexamethasone
administration of 0,1mg/kg Dexamethasone - 30 minutes before the popliteal nerve block
Arms:
0,1mg/kg Dexamethasone
Other names:
small dose
0,2mg/kg Dexamethasone
administration of 0,2mg/kg Dexamethasone - 30 minutes before the popliteal nerve block
Arms:
0,2mg/kg Dexamethasone
Other names:
large dose
Size
90
Primary endpoint
first need of opiate
48 hours
Eligibility criteria
Inclusion Criteria:
* children scheduled for ankle/foot surgery
* body weight \> 5kg
Exclusion Criteria:
* infection at the site of the regional blockade
* coagulation disorders
* immunodeficiency
* ASA= or \>4
* steroid medication in regular use
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ACTUAL'}}
Updated at
2024-02-28
1 organization
2 products
4 indications
Organization
Poznan University of Medical SciencesProduct
Sodium Chloride 0.9%Indication
Ankle DiseaseIndication
Foot DeformitiesIndication
Foot DiseasesIndication
Cerebral PalsyProduct
Dexamethasone