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

Phase 4

Completed

• Conditions: Post-operative Pain
• Interventions: Other: Placebo; Drug: Ibuprofen; Drug: Paracetamol

• Registration Number: NCT05602064
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study First Submitted: 2022-10-18
• Study First Submitted QC: 2022-10-29
• Study Start: 2022-11-01
• Study First Posted: 2022-11-01
• Status Verified: 2023-02
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-20
• Last Update Submitted: 2023-02-22
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group III (Placebo)	Placebo	The placebo solution will be freshly prepared by an assistant in a manner to match the color and odor of the analgesics
Group I (Ibuprofen)	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 II (Paracetamol)	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

Primary Outcome Measures

Name	Time	Method
Post-operative pain evaluation	Day1 (24 hours post-operatively)	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

Secondary Outcome Measures

Name	Time	Method
Trans-operative pain evaluation	Day 0 (During Procedure)	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.
Evaluation of parental anxiety	Day 0 (In the waiting room before the intervention)	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.
Evaluation of the child's dental anxiety	Day0 (In the waiting room before the intervention)	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.

Trial Locations

Locations (1)

Pediatric Dentistry department, Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt