Effectiveness of Pre-emptive Analgesics on Post-Operative Pain After Stainless Steel Crown Placement On Primary Molars

Alexandria University

Status and phase: Completed; Phase 4

Conditions: Post-operative Pain

Treatments: Other: Placebo; Drug: Ibuprofen; Drug: Paracetamol

Study type: Interventional

Funder types: Other

Identifiers

NCT05602064

270221

Details and patient eligibility

About

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

Full 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.

Enrollment: 66 patients

Sex: All

Ages: 5 to 8 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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66 participants in 3 patient groups, including a placebo group

Group I (Ibuprofen)

Experimental group

Description:

Participants will receive ibuprofen 100 mg/5 ml (BRUFEN®, Kahira Pharmaceuticals \& Chemical Industries Co.) The solution will be administered Once, 1 hour prior to the local anesthesia administration. The participant will receive a weight-dosed volume Effective dosages range from 10 mg/kg/day to a maximum of 40 mg/kg/day

Treatment:

Drug: Ibuprofen

Group II (Paracetamol)

Experimental group

Description:

Participants will receive paracetamol 250 mg/5 ml (CETAL®, EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.) The solution will be administered once, 1 hour prior to the local anesthesia administration. The participant will receive a weight-dosed volume Effective dosages are between 15-20mg/kg/day to a maximum of 60 mg/kg/day

Treatment:

Drug: Paracetamol

Group III (Placebo)

Placebo Comparator group

Description:

The placebo solution will be freshly prepared by an assistant in a manner to match the color and odor of the analgesics

Treatment:

Other: Placebo