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Completed

NCT Number: NCT05602064

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

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Key information

Conditions

Post-operative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

5 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Pediatric Dentistry department, Faculty of Dentistry, Alexandria University

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: BRUFEN®, Kahira Pharmaceuticals & Chemical Industries Co.

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

Other names: CETAL®, EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.

Placebo

Other

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

Primary outcomes

  1. Post-operative pain evaluation

    Time frame: Day 0 (Immediately 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

  2. Post-operative pain evaluation

    Time frame: Day 0 (2 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

  3. Post-operative pain evaluation

    Time frame: Day 0 (6 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

  4. Post-operative pain evaluation

    Time frame: 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 outcomes

  1. Trans-operative pain evaluation

    Time frame: 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.

  2. Evaluation of the child's dental anxiety

    Time frame: 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.

  3. Evaluation of parental anxiety

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 1, 2022
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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