NCT05602064 - Effectiveness of Pre-emptive Analgesics on Post-Operative Pain After Stainless Steel Crown Placement On Primary Molars | Crick

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

66

Conditions

Post-operative Pain

Interventions

IbuprofenDRUG

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

ParacetamolDRUG

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

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 5 YearsMax age: 8 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Pediatric Dentistry department, Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

Post-operative pain evaluation

Pain will be measured via a visual analogue scale (VAS) based on a straight line of 100 mm where 0 mm indicates absence of pain and 100 mm indicates greatest pain felt, and a facial pain scale.Children will self-report their level of pain four times post-operatively

Time frame: Day 0 (Immediately post-operatively)

Post-operative pain evaluation

Pain will be measured via a visual analogue scale (VAS) based on a straight line of 100 mm where 0 mm indicates absence of pain and 100 mm indicates greatest pain felt, and a facial pain scale.Children will self-report their level of pain four times post-operatively

Time frame: Day 0 (2 hours post-operatively)

Post-operative pain evaluation

Pain will be measured via a visual analogue scale (VAS) based on a straight line of 100 mm where 0 mm indicates absence of pain and 100 mm indicates greatest pain felt, and a facial pain scale.Children will self-report their level of pain four times post-operatively

Time frame: Day 0 (6 hours post-operatively)

Post-operative pain evaluation

Pain will be measured via a visual analogue scale (VAS) based on a straight line of 100 mm where 0 mm indicates absence of pain and 100 mm indicates greatest pain felt, and a facial pain scale.Children will self-report their level of pain four times post-operatively

Time frame: Day1 (24 hours post-operatively)

Secondary Outcomes

Trans-operative pain evaluation

To assess the effectiveness of pre-emptive analgesics in reducing pain during local anesthesia administration, after local anesthesia administration, the child will be shown the Visual analogue scale (VAS) based on a straight line of 100 mm where 0 mm indicates absence of pain and 100 mm indicates greatest pain felt, and a Facial Pain Scale (FPS). He/she will be asked to choose the score or face which best describes the level he/she felt during administration of the anesthetic solution.