Clinical trial NCT05602064: Effectiveness of Pre-emptive Analgesics on Post-Operative Pain After Stainless Steel Crown Placement On Primary Molars
Official title: Effectiveness of Pre-emptive Analgesics on Post-Operative Pain After Stainless Steel Crown Placement On Primary Molars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post-operative Pain
Keywords: Pre-emptive analgesia
ibuprofen
paracetamol
post-operative pain
stainless steel crown
Primary molars
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 66
Sex: ALL
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effectiveness of pre-emptive analgesia using ibuprofen and paracetamol on reducing post-operative pain following the placement of stainless steel crowns on primary molars compared to placebo

Detailed description: The study will be a parallel, placebo-controlled, triple-blinded, randomized clinical trial. A total of 66 healthy children aged 5-8 years requiring the placement of a stainless steel crown will be selected from Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, Egypt. The children will be randomly allocated into three groups according to the type of pre-emptive solution used. Group I will receive ibuprofen, group II will receive paracetamol, while group III (control) will receive a placebo solution. Children will self-report their level of pain using a Visual analogue scale (VAS) and/or a Facial pain scale (FPS) after local anesthesia administration, immediately after the cementation of the stainless steel crown, and 2, 6 and 24 hours post-operatively. Children's baseline anxiety and parental anxiety will also be assessed.

Eligibility criteria: Inclusion Criteria:

Participant inclusion criteria:

* Age range 5 to 8 years old
* Children without any previous interventional dental experience
* Children free of any systemic disease or special health care needs (ASA 1)
* Children free of any allergies or hypersensitivity reactions to local anesthetics or analgesic drugs
* Positive or definitely positive behaviour during preoperative assessments according to the Frankl Rating Scale (score 3 or 4)
* Parents/caregivers and children who are willing to participate in the study

Tooth inclusion criteria:

* Maxillary first or second primary molar teeth with extensive and/or multisurface caries where other restorations are likely to fail but without pulp exposure
* Absence of clinical and radiographic signs or symptoms of irreversible pulpitis
* Absence of fistula or abscess near the selected tooth clinically and radiographically
* Absence of spontaneous pain
* Absence of pulp exposure
* Absence of pathological mobility by placing the points of a pair of tweezers in an occlusal fossa, and gently rocking the tooth bucco-lingually

Primary outcomes:
measure: Post-operative pain evaluation
timeFrame: Day 0 (Immediately post-operatively)
measure: Post-operative pain evaluation
timeFrame: Day 0 (2 hours post-operatively)
measure: Post-operative pain evaluation
timeFrame: Day 0 (6 hours post-operatively)
measure: Post-operative pain evaluation
timeFrame: Day1 (24 hours post-operatively)
Secondary outcomes:
measure: Trans-operative pain evaluation
timeFrame: Day 0 (During Procedure)
measure: Evaluation of the child's dental anxiety
timeFrame: Day0 (In the waiting room before the intervention)
measure: Evaluation of parental anxiety
timeFrame: Day 0 (In the waiting room before the intervention)
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Pediatric Dentistry department, Faculty of Dentistry, Alexandria University
Study officials:
References: