Back to resultsEffectiveness of Pre-emptive Analgesics on Post-Operative Pain After Stainless Steel Crown Placement On Primary Molars
Primary Purpose
Post-operative Pain
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Ibuprofen
Paracetamol
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain focused on measuring Pre-emptive analgesia, ibuprofen, paracetamol, post-operative pain, stainless steel crown, Primary molars
Eligibility Criteria
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
Sites / Locations
- Pediatric Dentistry department, Faculty of Dentistry, Alexandria University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Group I (Ibuprofen)
Group II (Paracetamol)
Group III (Placebo)
Arm Description
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
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
The placebo solution will be freshly prepared by an assistant in a manner to match the color and odor of the analgesics
Outcomes
Primary Outcome Measures
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
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
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
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
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05602064
First Posted
October 18, 2022
Last Updated
February 22, 2023
Sponsor
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT05602064
Brief Title
Effectiveness of Pre-emptive Analgesics on Post-Operative Pain After Stainless Steel Crown Placement On Primary Molars
Official Title
Effectiveness of Pre-emptive Analgesics on Post-Operative Pain After Stainless Steel Crown Placement On Primary Molars
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
Pre-emptive analgesia, ibuprofen, paracetamol, post-operative pain, stainless steel crown, Primary molars
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I (Ibuprofen)
Arm Type
Experimental
Arm Description
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
Arm Title
Group II (Paracetamol)
Arm Type
Experimental
Arm Description
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
Arm Title
Group III (Placebo)
Arm Type
Placebo Comparator
Arm Description
The placebo solution will be freshly prepared by an assistant in a manner to match the color and odor of the analgesics
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Other Intervention Name(s)
BRUFEN®, Kahira Pharmaceuticals & Chemical Industries Co.
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Other Intervention Name(s)
CETAL®, EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
A placebo solution will be freshly prepared by an assistant in a manner to match the color and odor of the analgesics
Primary Outcome Measure Information:
Title
Post-operative pain evaluation
Description
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
Time Frame
Day 0 (Immediately post-operatively)
Title
Post-operative pain evaluation
Description
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
Time Frame
Day 0 (2 hours post-operatively)
Title
Post-operative pain evaluation
Description
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
Time Frame
Day 0 (6 hours post-operatively)
Title
Post-operative pain evaluation
Description
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
Time Frame
Day1 (24 hours post-operatively)
Secondary Outcome Measure Information:
Title
Trans-operative pain evaluation
Description
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.
Time Frame
Day 0 (During Procedure)
Title
Evaluation of the child's dental anxiety
Description
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.
Time Frame
Day0 (In the waiting room before the intervention)
Title
Evaluation of parental anxiety
Description
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.
Time Frame
Day 0 (In the waiting room before the intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Pediatric Dentistry department, Faculty of Dentistry, Alexandria University
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Pre-emptive Analgesics on Post-Operative Pain After Stainless Steel Crown Placement On Primary Molars
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