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

Post-operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05602064
• Other study ID #: 270221
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: February 2023
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 20, 2023
• Est. primary completion date: February 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post-operative Pain

Intervention

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

Locations

Country	Name	City	State
Egypt	Pediatric Dentistry department, Faculty of Dentistry, Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)