Post-operative PainPhase 4NCT05602064
Effectiveness of Pre-emptive Analgesics on Post-Operative Pain After Stainless Steel Crown Placement On Primary Molars
A Phase 4 study testing Ibuprofen and Paracetamol in people with Post-operative Pain, run by Alexandria University at 1 site in Egypt.
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 Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Ibuprofen and Paracetamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 20 Feb 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Show all 14Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pediatric Dentistry department, Faculty of Dentistry, Alexandria University
Alexandria
About this study
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
Read the 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.
- Conditions
- Post-operative Pain
- Being tested
- Ibuprofen, Paracetamol, Placebo
- Keywords
- Pre-emptive analgesia, ibuprofen, paracetamol, post-operative pain, stainless steel crown, Primary molars
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called BRUFEN®, Kahira Pharmaceuticals & Chemical Industries Co.
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
ParacetamolDrug
Also called CETAL®, EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.
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
PlaceboOther
A placebo solution will be freshly prepared by an assistant in a manner to match the color and odor of the analgesics
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Day1 (24 hours post-operatively)
Secondary outcomes (3)
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.
Measured: Day 0 (During Procedure)
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.
Measured: Day0 (In the waiting room before the intervention)
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.
Measured: Day 0 (In the waiting room before the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2022
- Study start1 Nov 2022
- Primary completion1 Feb 2023
- Study completion20 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farah Nemr, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05602064
- Sponsor's protocol ID
- 270221
- Status last verified
- Feb 2023
- First submitted
- 18 Oct 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Pre-emptive Analgesics on Post-Operative Pain After Stainless Steel Crown Placement On Primary Molars
- ClinicalTrials.gov ID
- NCT05602064
- Acronym / sponsor ID
- 270221
- Conditions
- Post-operative Pain
- Keywords
- Pre-emptive analgesia, ibuprofen, paracetamol, post-operative pain, stainless steel crown, Primary molars
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 20 Feb 2023 (actual)
- First posted
- 1 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (Ibuprofen) | Experimental | Drug: IbuprofenParticipants 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) | Experimental | Drug: ParacetamolParticipants 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 |
| Group III (Placebo) | Placebo comparator | Other: PlaceboThe placebo solution will be freshly prepared by an assistant in a manner to match the color and odor of the analgesics |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IbuprofenAlso: BRUFEN®, Kahira Pharmaceuticals & Chemical Industries Co.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 | Drug | Group I (Ibuprofen) |
| ParacetamolAlso: CETAL®, EGYPTIAN INT. PHARMACEUTICAL INDUSTRIES CO.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 | Drug | Group II (Paracetamol) |
| PlaceboA placebo solution will be freshly prepared by an assistant in a manner to match the color and odor of the analgesics | Other | Group III (Placebo) |
Primary outcome
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
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
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
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
3 secondary outcomes
Trans-operative pain evaluation
Time frame: Day 0 (During Procedure)
Evaluation of the child's dental anxiety
Time frame: Day0 (In the waiting room before the intervention)
Evaluation of parental anxiety
Time frame: Day 0 (In the waiting room before the intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Post-operative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ibuprofen and Paracetamol in people with Post-operative Pain, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain evaluation (time frame: Day 0 (Immediately post-operatively)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.