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

NCT05602064 | Completed Phase 4

• 1 other identifier: 270221
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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

Conditions

Post-operative Pain

Keywords

Pre-emptive analgesia; ibuprofen; paracetamol; post-operative pain; stainless steel crown; Primary molars

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Trans-operative pain evaluation

  Day 0 (During Procedure)

• Evaluation of the child's dental anxiety

  Day0 (In the waiting room before the intervention)

• Evaluation of parental anxiety

  Day 0 (In the waiting room before the intervention)

Study Arms (3)

Group I (Ibuprofen)

EXPERIMENTAL

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

Group II (Paracetamol)

EXPERIMENTAL

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

Group III (Placebo)

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Ibuprofen 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

Also known as: BRUFEN®, Kahira Pharmaceuticals & Chemical Industries Co.

Group I (Ibuprofen)

Paracetamol 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

Also known as: CETAL®, EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.

Group II (Paracetamol)

Placebo OTHER

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

Group III (Placebo)

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Pediatric Dentistry department, Faculty of Dentistry, Alexandria University

Alexandria, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ibuprofen; Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: November 1, 2022
• Study Start: November 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 20, 2023
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)