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

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

Study Overview

• Status: Completed
• Conditions: Post-operative Pain
• Intervention / Treatment: Drug: Ibuprofen; Drug: Paracetamol; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Farah Nemr; Phone Number: 0201002153085; Email: farahsnemr@gmail.com
• Study Contact Backup: Name: Farah Nemr; Phone Number: +447446515000; Email: farahelnemr@gmail.com

Study Locations

• Egypt
  • Alexandria, Egypt
    • Pediatric Dentistry department, Faculty of Dentistry, Alexandria University
    • Contact: Faculty of Dentistry Alexandria University; Phone Number: 203 02034868308; Email: dent.admin@alexu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 8 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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; Other Names: BRUFEN®, Kahira Pharmaceuticals & Chemical Industries Co.
Experimental: 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	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; Other Names: CETAL®, EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.
Placebo Comparator: 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	Other: Placebo; A placebo solution will be freshly prepared by an assistant in a manner to match the color and odor of the analgesics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	Day1 (24 hours post-operatively)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 0 (During Procedure)
Evaluation of the child's dental anxiety	To assess the child's anxiety, the Arabic version of the faces version of Modified Child Dental Anxiety Scale (MCDASf) will be used.The MCDAS consists of eight questions to assess dental anxiety about specific dental procedures. A five-point Likert scale is used to determine dental anxiety with scores ranging from 'relaxed/not worried' to 'very worried'. The faces version of Modified Child Dental Anxiety Scale (MCDASf) has a faces analogue scale anchored above the original numeric form.	Day0 (In the waiting room before the intervention)
Evaluation of parental anxiety	Parental anxiety will be evaluated using the Arabic version of the Modified Dental Anxiety Scale (MDAS) which consists of 5 questions with a score of 0 to 4, where 0 indicates absence of anxiety and 4 indicates being extremely anxious.	Day 0 (In the waiting room before the intervention)

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 20, 2023

Study Registration Dates

• First Submitted: October 18, 2022
• First Submitted That Met QC Criteria: October 29, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Estimate): February 23, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: ibuprofen; paracetamol; Primary molars; post-operative pain; Pre-emptive analgesia; stainless steel crown
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Acetaminophen; Ibuprofen
• Other Study ID Numbers: 270221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No