Analgesic DrugsPhase 1/2NCT03184649
Ibuprofen, Paracetamol Versus Placebo on Pain During Local Anesthetic Injection (RCT)
A Phase 1/2 study testing Ibuprofen and paracetamol in people with Analgesic Drugs and Pain Relief, run by Cairo University at 1 site in Egypt.
Trial summary
The Effect of Ibuprofen, Paracetamol versus Placebo on Pain during Local Anesthetic Injection and Following Dental Extraction in Primary Molars: A Randomized clinical trial Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesic Drugs, Pain Relief
- What is being tested?
- Ibuprofen and paracetamol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2017to 1 Dec 2017
- Phase
- Phase 1/2
- 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 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 7-12 years who need extractions under local anesthesia.
- Those having a parent/guardian to understand and comply with the requirements of the protocol and able to fill an appropriate written informed consent.
- Children and parents who agree to wait for the stipulated time before and after the extraction.
Who cannot join
- Children with acute pain.
- Patients taking analgesics within 5 hours prior to the dental extraction.
- Patients with a history of prolonged bleeding, platelet disorders, hypersensitivity, or allergic reactions to analgesics or any of the drugs tested.
- Patients without a home telephone or without parental supervision for the post- operative period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Ibuprofen, Paracetamol Versus Placebo on Pain During Local Anesthetic Injection and Following Dental Extraction in Primary Molars: A Randomized Clinical Trial
The Effect of Ibuprofen, Paracetamol versus Placebo on Pain during Local Anesthetic Injection and Following Dental Extraction in Primary Molars: A Randomized clinical trial
Read the detailed description
- Diagnosis:
- Diagnostic chart will be filled with personal, medical and dental history. DMF and def.
- Clinical examination (intra oral and extra oral) will be done by mirror and probe to assess the inclusion criteria. All materials will be packaged in sterilizations wraps and autoclave following the required bio safety standards.
- Intervention:
Experimental Groups:
Group 1: Ibuprofen suspension (Ibufen®, 100 mg/5 mL; fruit flavored, orange colour, Abbott). Group 2: Paracetamol (Calpol™, 250 mg/5 mL; fruit flavored, orange color, GlaxoSmithKline).
Comparative Group:
Group 3: A fruit-flavored orange color placebo solution.
Clinical procedure:
- The drugs in all of the groups will be prepared in a fruit-flavored solution of the same color and scent.
- Patients will be blind to one of the three pre-treatment drug groups.
- Containers of each solution will be prepared and number-coded with the slips of paper by the assistant supervisor. The containers will be the same for all treatment groups except for the number coded with slips of paper.
- Both the researcher and the child/parent will be blind to the content of the container.
- The assigned solution will be taken by the patient at various times before administration of the local anesthetic agent. Ibuprofen 30 min before injection of local anesthesia paracetamol 60 min before injection of local anesthesia Placebo solution 60 min before injection of local anesthesia
- The time of the preoperative solution administration will be recorded on the data sheet.
- Topical anesthesia in the form of benzocaine gel 20% will be applied to the dried mucosa. All the children will be given 2% lidocaine with a 1:80,000 epinephrine injection for local anesthesia sufficient for obtaining adequate anesthesia.
- All teeth will be extracted with a minimum of surgical trauma in an uncomplicated fashion.
Recording data
- Pain scores will be recorded in the Pediatric Dental Clinic using a five-face scale that had been previously validated.
- This scale has shown good construct validity as a self-report pain measure. It measures an affective dimension of a child's pain experience after injection and teeth extraction and is used in children aged 7-12 years.
- It is easy to use and giving consistent scores from 0 to 4. It can be used for the subjective evaluation of feelings after the performance of painful dental procedures.
- The child will be shown to a set of five cartoon faces with varying facial expressions ranging from a smile/laughter to tears. The scores given are: (0) No sign of pain. (1) Mild pain. (2) Moderate pain. (3) Severe pain. (4) Very severe pain.
- Conditions
- Analgesic Drugs, Pain Relief
- Being tested
- Ibuprofen, paracetamol, A fruit-flavored orange color placebo solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
Also called Ibufen®
It is a pre-analgesic will be taken before painful procedures.
paracetamolDrug
Also called calpol®
it is a pre-analgesic drug will be taken before painful procedure.
A fruit-flavored orange color placebo solutionDietary supplement
Also called orange juice
orange juice as a comparative group.
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | Ibuprofen suspension (Ibufen®, 100 mg/5 mL; fruit flavored, orange colour, Abbott) will be given 30 min before injection of local anesthesia. Then pain scores will be recorded from 0-4. Receives: Drug: Ibuprofen |
| intervention | Experimental | Paracetamol (Calpol™, 250 mg/5 mL; fruit flavored, orange color, GlaxoSmithKline) will be given 60 min before injection of local anesthesia.Then pain scores will be recorded from 0-4. Receives: Drug: paracetamol |
| comparator | Placebo comparator | A fruit-flavored orange color placebo solution will be given 60 min before injection of local anesthesia.Then pain scores will be recorded from 0-4. Receives: Dietary Supplement: A fruit-flavored orange color placebo solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
categorical score
mild, moderate, sever, very sever
Measured: 1 hour
Secondary outcomes (1)
binary
yes or no
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start1 May 2017
- Primary completion1 Sep 2017 (estimated)
- Study completion1 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Analgesic DrugsStudies of the same condition, open and under way.
- More trials run by Cairo 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- three groups, two for intervention and one for comparative group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Abdelrahman Elshenawy, Cairo University
- Investigators
- fatma A. Elshehaby, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184649
- Sponsor's protocol ID
- RAElshenawy
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2017
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: i will be available after finished
Publications
Gazal G, Mackie IC. A comparison of paracetamol, ibuprofen or their combination for pain relief following extractions in children under general anaesthesia: a randomized controlled trial. Int J Paediatr Dent. 2007 May;17(3):169-77. doi: 10.1111/j.1365-263X.2006.00806.x.
PubMed 17397460
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ibuprofen, Paracetamol Versus Placebo on Pain During Local Anesthetic Injection and Following Dental Extraction in Primary Molars: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03184649
- Acronym / sponsor ID
- RAElshenawy
- Conditions
- Analgesic Drugs, Pain Relief
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Sep 2017 (estimated)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 12 Jun 2017 (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 Effect of Ibuprofen, Paracetamol versus Placebo on Pain during Local Anesthetic Injection and Following Dental Extraction in Primary Molars: A Randomized clinical trial
Detailed description
- Diagnosis:
- Diagnostic chart will be filled with personal, medical and dental history. DMF and def.
- Clinical examination (intra oral and extra oral) will be done by mirror and probe to assess the inclusion criteria. All materials will be packaged in sterilizations wraps and autoclave following the required bio safety standards.
- Intervention:
Experimental Groups:
Group 1: Ibuprofen suspension (Ibufen®, 100 mg/5 mL; fruit flavored, orange colour, Abbott). Group 2: Paracetamol (Calpol™, 250 mg/5 mL; fruit flavored, orange color, GlaxoSmithKline).
Comparative Group:
Group 3: A fruit-flavored orange color placebo solution.
Clinical procedure:
- The drugs in all of the groups will be prepared in a fruit-flavored solution of the same color and scent.
- Patients will be blind to one of the three pre-treatment drug groups.
- Containers of each solution will be prepared and number-coded with the slips of paper by the assistant supervisor. The containers will be the same for all treatment groups except for the number coded with slips of paper.
- Both the researcher and the child/parent will be blind to the content of the container.
- The assigned solution will be taken by the patient at various times before administration of the local anesthetic agent. Ibuprofen 30 min before injection of local anesthesia paracetamol 60 min before injection of local anesthesia Placebo solution 60 min before injection of local anesthesia
- The time of the preoperative solution administration will be recorded on the data sheet.
- Topical anesthesia in the form of benzocaine gel 20% will be applied to the dried mucosa. All the children will be given 2% lidocaine with a 1:80,000 epinephrine injection for local anesthesia sufficient for obtaining adequate anesthesia.
- All teeth will be extracted with a minimum of surgical trauma in an uncomplicated fashion.
Recording data
- Pain scores will be recorded in the Pediatric Dental Clinic using a five-face scale that had been previously validated.
- This scale has shown good construct validity as a self-report pain measure. It measures an affective dimension of a child's pain experience after injection and teeth extraction and is used in children aged 7-12 years.
- It is easy to use and giving consistent scores from 0 to 4. It can be used for the subjective evaluation of feelings after the performance of painful dental procedures.
- The child will be shown to a set of five cartoon faces with varying facial expressions ranging from a smile/laughter to tears. The scores given are: (0) No sign of pain. (1) Mild pain. (2) Moderate pain. (3) Severe pain. (4) Very severe pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- three groups, two for intervention and one for comparative group
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Drug: IbuprofenIbuprofen suspension (Ibufen®, 100 mg/5 mL; fruit flavored, orange colour, Abbott) will be given 30 min before injection of local anesthesia. Then pain scores will be recorded from 0-4. |
| intervention | Experimental | Drug: paracetamolParacetamol (Calpol™, 250 mg/5 mL; fruit flavored, orange color, GlaxoSmithKline) will be given 60 min before injection of local anesthesia.Then pain scores will be recorded from 0-4. |
| comparator | Placebo comparator | Dietary Supplement: A fruit-flavored orange color placebo solutionA fruit-flavored orange color placebo solution will be given 60 min before injection of local anesthesia.Then pain scores will be recorded from 0-4. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 7-12 years who need extractions under local anesthesia.
- Those having a parent/guardian to understand and comply with the requirements of the protocol and able to fill an appropriate written informed consent.
- Children and parents who agree to wait for the stipulated time before and after the extraction.
Key exclusion criteria (4 listed)
- Children with acute pain.
- Patients taking analgesics within 5 hours prior to the dental extraction.
- Patients with a history of prolonged bleeding, platelet disorders, hypersensitivity, or allergic reactions to analgesics or any of the drugs tested.
- Patients without a home telephone or without parental supervision for the post- operative period.
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: Ibufen®It is a pre-analgesic will be taken before painful procedures. | Drug | intervention arm |
| paracetamolAlso: calpol®it is a pre-analgesic drug will be taken before painful procedure. | Drug | intervention |
| A fruit-flavored orange color placebo solutionAlso: orange juiceorange juice as a comparative group. | Dietary supplement | comparator |
Primary outcome
categorical score
Time frame: 1 hour
mild, moderate, sever, very sever
1 secondary outcome
binary
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Results publication: PubMed 17397460Gazal G, Mackie IC. A comparison of paracetamol, ibuprofen or their combination for pain relief following extractions in children under general anaesthesia: a randomized controlled trial. Int J Paediatr Dent. 2007 May;17(3):169-77. doi: 10.1111/j.1365-263X.2006.00806.x.
- Description paperLink provided by the sponsor.
- Individual participant dataSharing planned: No. i will be available after finished
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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.
fatma A. Elshehaby, Professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ibuprofen and paracetamol in people with Analgesic Drugs and Pain Relief, run by Cairo 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Jun 2017. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
categorical score (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03184649, which also lists 1 linked publication.
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 14 Jun 2017.