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

NCT ID: NCT05602064

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-02-20

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.

Conditions

Post-operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group I (Ibuprofen)

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

Group Type: EXPERIMENTAL

Ibuprofen

Intervention Type: DRUG

Ibuprofen is a non-steroidal anti-inflammatory drug which acts by reducing the production of cyclo-oxygenases (COX-1 and COX-2)- derived prostanoids in the blood

Group II (Paracetamol)

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

Group Type: EXPERIMENTAL

Paracetamol

Intervention Type: DRUG

Paracetamol is an analgesic that acts peripherally; although its primary site of action is still debatable, it is thought to inhibit prostaglandins in the hypothalamus

Group III (Placebo)

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Ibuprofen

Ibuprofen is a non-steroidal anti-inflammatory drug which acts by reducing the production of cyclo-oxygenases (COX-1 and COX-2)- derived prostanoids in the blood

Intervention Type: DRUG

Paracetamol

Paracetamol is an analgesic that acts peripherally; although its primary site of action is still debatable, it is thought to inhibit prostaglandins in the hypothalamus

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

BRUFEN®, Kahira Pharmaceuticals & Chemical Industries Co.; CETAL®, EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Farah Nemr

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Pediatric Dentistry department, Faculty of Dentistry, Alexandria University

Alexandria, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

270221

Identifier Type: -

Identifier Source: org_study_id