Local AnesthesiaPhase 2/3NCT03786029
Pre-emptive Analgesic Administration in Primary Tooth Extraction
A Phase 2/3 study testing Acetaminophen and Ibuprofen in people with Local Anesthesia and Tooth Extraction, run by Latakia University at 1 site in Syria.
Trial summary
Brief Summary: Aims: The objective of the current study will be to compare the effectiveness of Ibuprofen, Acetaminophen, and Placebo on reducing injection pain and post-operative pain in primary tooth extraction, and to compare the parents' satisfaction. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Local Anesthesia, Tooth Extraction
- What is being tested?
- Acetaminophen and Ibuprofen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteSyria
- Study dates
- 1 Apr 2019to 10 Jun 2019
- Phase
- Phase 2/3
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Teeth with an abscess or infection exceeding one-third of the interradicular area (not exceeding the oral cavity) 2. Unrestorable decayed teeth. 3. Teeth with periapical / interradicular lesions.
- -
Who cannot join
- Teeth with advanced root resorption (a third of the root at least)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Pre-emptive Ibuprofen, Acetaminophen, and Placebo Administration in Reducing Local Anesthesia Injection Pain and Post-operative Pain in Primary Tooth Extraction. A Clinical Study
Brief Summary:
Aims: The objective of the current study will be to compare the effectiveness of Ibuprofen, Acetaminophen, and Placebo on reducing injection pain and post-operative pain in primary tooth extraction, and to compare the parents' satisfaction.
Design: This will be a blinded, randomized placebo-controlled trial including sixty six cooperative children, aged 6-8 years old.
Read the detailed description
Background and Aims: The pain could be a problem for the patients during the first few hours after the extraction because of both soft and hard tissues trauma during the operation, despite that the local anesthesia will last for a long time in most of the cases.
There are no enough studies that ensure the validity of giving any analgesic in reducing injection pain and post-operative pain in primary tooth extraction so far.
Design: This will be a blinded, randomized placebo-controlled trial including sixty six cooperative children, aged 6-8 years old, randomly assigned to one of three groups to receive one of the oral suspension drugs, that have the same colour and taste, via pre-calibrated medication bottles, which are identical, numbered and containing the same amount of pre-calibrated dosages, as per the following portions:
- Acetaminophen syrup: 160mg/5ml
- Placebo solution
- Ibuprofen suspension: 100mg/5ml
- Conditions
- Local Anesthesia, Tooth Extraction
- Being tested
- Acetaminophen, Placebo, Ibuprofen
- Keywords
- Pre-emptive administration, Analgesic, Tooth extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called A
Patients will receive 320mg (10ml) Acetaminophen (Strawberry flavour), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection.
The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction.
Pain will be re-evaluated 15 minutes after the extraction.
The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home.
Parents' satisfaction will be evaluated using Likert fifth scale.
PlaceboDrug
Also called B
Patients will receive 10ml Strawberry Juice (placebo), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection.
The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction.
Pain will be re-evaluated 15 minutes after the extraction.
The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home.
Parents' satisfaction will be evaluated using Likert fifth scale.
IbuprofenDrug
Also called C
Patients will receive 200mg (10ml) of Ibuprofen (Strawberry flavour), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection.
The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction.
Pain will be re-evaluated 15 minutes after the extraction.
The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home.
Parents' satisfaction will be evaluated using Likert fifth scale.
| Study group | Role | What they receive |
|---|---|---|
| A (Acetaminophen) | Experimental | 22 children will receive 320mg (10ml) 30 minutes before the local anesthesia injection. Receives: Drug: Acetaminophen |
| B (Placebo) | Placebo comparator | 22 children will receive 10ml 30 minutes before the local anesthesia injection. Receives: Drug: Placebo |
| C (Ibuprofen) | Experimental | 22 children will receive 200mg (10ml) 30 minutes before the local anesthesia injection. Receives: Drug: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment pain related to the injection of the local anesthesia using WBFS.
The Wong-Baker Faces Pain Rating Scale (WBFS) is a pain scale that shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain.
Immediately after the injection, the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale, WBFS.
Measured: 30-60 seconds after injection of the local anesthesia.
Post operative pain assessment using WBFS.
After 10minutes from the injection and immediately after the extraction, the child will be asked to point to the face that fits the degree of pain on the same scale.
Re-evaluate the pain after 15minutes from the extraction.
The scale will be given to the parents to evaluate the pain post-extraction after an hour to 6 hours while the child is at home.
Measured: 10 minutes - 6 hours after the extraction.
Secondary outcomes (1)
Evaluate the parents' satisfaction using Likert fifth scale.
After the post-operation pain assessment is being done by the parents, the Likert fifth scale is used to determined the degree of parents satisfaction by choosing one of the following degrees: strongly agree, agree, neutral, disagree, strongly disagree.
Measured: 6 hours after extraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start1 Apr 2019
- Primary completion1 Jun 2019
- Study completion10 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Local AnesthesiaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blinded, randomized placebo-controlled trial, comparing three groups.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Latakia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nabih Raslan, Latakia University
- Investigators
- Nabih Raslan, Dr, Study chair, Latakia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03786029
- Sponsor's protocol ID
- Tishreen - Pre-emptive
- Status last verified
- Jun 2019
- First submitted
- 15 Dec 2018
- Last updated
- 18 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Up to date, there is no decision about IPD sharing.
Publications
Ashley PF, Parekh S, Moles DR, Anand P, MacDonald LC. Preoperative analgesics for additional pain relief in children and adolescents having dental treatment. Cochrane Database Syst Rev. 2016 Aug 8;2016(8):CD008392. doi: 10.1002/14651858.CD008392.pub3.
PubMed 27501304Pozos-Guillen A, Martinez-Rider R, Aguirre-Banuelos P, Perez-Urizar J. Pre-emptive analgesic effect of tramadol after mandibular third molar extraction: a pilot study. J Oral Maxillofac Surg. 2007 Jul;65(7):1315-20. doi: 10.1016/j.joms.2006.10.079.
PubMed 17577495Gazal 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 17397460Baygin O, Tuzuner T, Isik B, Kusgoz A, Tanriver M. Comparison of pre-emptive ibuprofen, paracetamol, and placebo administration in reducing post-operative pain in primary tooth extraction. Int J Paediatr Dent. 2011 Jul;21(4):306-13. doi: 10.1111/j.1365-263X.2011.01124.x. Epub 2011 Apr 6.
PubMed 21470320Ashkenazi M, Blumer S, Eli I. Post-operative pain and use of analgesic agents in children following intrasulcular anaesthesia and various operative procedures. Br Dent J. 2007 Mar 10;202(5):E13; discussion 276-7. doi: 10.1038/bdj.2007.81. Epub 2007 Feb 2.
PubMed 17273178Jurgens S, Warwick RS, Inglehearn PJ, Gooneratne DS. Pain relief for paediatric dental chair anaesthesia: current practice in a community dental clinic. Int J Paediatr Dent. 2003 Mar;13(2):93-7. doi: 10.1046/j.1365-263x.2003.00430.x.
PubMed 12605626Primosch RE, Nichols DL, Courts FJ. Comparison of preoperative ibuprofen, acetaminophen, and placebo administration on the parental report of postextraction pain in children. Pediatr Dent. 1995 May-Jun;17(3):187-91.
PubMed 7617493McGaw T, Raborn W, Grace M. Analgesics in pediatric dental surgery: relative efficacy of aluminum ibuprofen suspension and acetaminophen elixir. ASDC J Dent Child. 1987 Mar-Apr;54(2):106-9.
PubMed 3470325
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pre-emptive Ibuprofen, Acetaminophen, and Placebo Administration in Reducing Local Anesthesia Injection Pain and Post-operative Pain in Primary Tooth Extraction. A Clinical Study
- ClinicalTrials.gov ID
- NCT03786029
- Acronym / sponsor ID
- Tishreen - Pre-emptive
- Conditions
- Local Anesthesia, Tooth Extraction
- Keywords
- Pre-emptive administration, Analgesic, Tooth extraction
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Latakia UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 10 Jun 2019 (actual)
- First posted
- 24 Dec 2018 (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.
Brief Summary:
Aims: The objective of the current study will be to compare the effectiveness of Ibuprofen, Acetaminophen, and Placebo on reducing injection pain and post-operative pain in primary tooth extraction, and to compare the parents' satisfaction.
Design: This will be a blinded, randomized placebo-controlled trial including sixty six cooperative children, aged 6-8 years old.
Detailed description
Background and Aims: The pain could be a problem for the patients during the first few hours after the extraction because of both soft and hard tissues trauma during the operation, despite that the local anesthesia will last for a long time in most of the cases.
There are no enough studies that ensure the validity of giving any analgesic in reducing injection pain and post-operative pain in primary tooth extraction so far.
Design: This will be a blinded, randomized placebo-controlled trial including sixty six cooperative children, aged 6-8 years old, randomly assigned to one of three groups to receive one of the oral suspension drugs, that have the same colour and taste, via pre-calibrated medication bottles, which are identical, numbered and containing the same amount of pre-calibrated dosages, as per the following portions:
- Acetaminophen syrup: 160mg/5ml
- Placebo solution
- Ibuprofen suspension: 100mg/5ml
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Blinded, randomized placebo-controlled trial, comparing three groups.
| Arm | Type | Receives |
|---|---|---|
| A (Acetaminophen) | Experimental | Drug: Acetaminophen22 children will receive 320mg (10ml) 30 minutes before the local anesthesia injection. |
| B (Placebo) | Placebo comparator | Drug: Placebo22 children will receive 10ml 30 minutes before the local anesthesia injection. |
| C (Ibuprofen) | Experimental | Drug: Ibuprofen22 children will receive 200mg (10ml) 30 minutes before the local anesthesia injection. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 1. Teeth with an abscess or infection exceeding one-third of the interradicular area (not exceeding the oral cavity) 2. Unrestorable decayed teeth. 3. Teeth with periapical / interradicular lesions.
- -
Key exclusion criteria (1 listed)
- Teeth with advanced root resorption (a third of the root at least)
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 |
|---|---|---|
| AcetaminophenAlso: APatients will receive 320mg (10ml) Acetaminophen (Strawberry flavour), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection. The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction. Pain will be re-evaluated 15 minutes after the extraction. The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home. Parents' satisfaction will be evaluated using Likert fifth scale. | Drug | A (Acetaminophen) |
| PlaceboAlso: BPatients will receive 10ml Strawberry Juice (placebo), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection. The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction. Pain will be re-evaluated 15 minutes after the extraction. The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home. Parents' satisfaction will be evaluated using Likert fifth scale. | Drug | B (Placebo) |
| IbuprofenAlso: CPatients will receive 200mg (10ml) of Ibuprofen (Strawberry flavour), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection. The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction. Pain will be re-evaluated 15 minutes after the extraction. The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home. Parents' satisfaction will be evaluated using Likert fifth scale. | Drug | C (Ibuprofen) |
Primary outcome
Assessment pain related to the injection of the local anesthesia using WBFS.
Time frame: 30-60 seconds after injection of the local anesthesia.
The Wong-Baker Faces Pain Rating Scale (WBFS) is a pain scale that shows a series of faces ranging from a happy face at 0, or "no hurt", to a crying face at 10, which represents "hurts like the worst pain imaginable". Based on the faces and written descriptions, the patient chooses the face that best describes their level of pain. Immediately after the injection, the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale, WBFS.
Post operative pain assessment using WBFS.
Time frame: 10 minutes - 6 hours after the extraction.
After 10minutes from the injection and immediately after the extraction, the child will be asked to point to the face that fits the degree of pain on the same scale. Re-evaluate the pain after 15minutes from the extraction. The scale will be given to the parents to evaluate the pain post-extraction after an hour to 6 hours while the child is at home.
1 secondary outcome
Evaluate the parents' satisfaction using Likert fifth scale.
Time frame: 6 hours after extraction.
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 18 Jun 2019.
- Background: PubMed 27501304Ashley PF, Parekh S, Moles DR, Anand P, MacDonald LC. Preoperative analgesics for additional pain relief in children and adolescents having dental treatment. Cochrane Database Syst Rev. 2016 Aug 8;2016(8):CD008392. doi: 10.1002/14651858.CD008392.pub3.
- Background: PubMed 17577495Pozos-Guillen A, Martinez-Rider R, Aguirre-Banuelos P, Perez-Urizar J. Pre-emptive analgesic effect of tramadol after mandibular third molar extraction: a pilot study. J Oral Maxillofac Surg. 2007 Jul;65(7):1315-20. doi: 10.1016/j.joms.2006.10.079.
- Background: 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.
- Background: PubMed 21470320Baygin O, Tuzuner T, Isik B, Kusgoz A, Tanriver M. Comparison of pre-emptive ibuprofen, paracetamol, and placebo administration in reducing post-operative pain in primary tooth extraction. Int J Paediatr Dent. 2011 Jul;21(4):306-13. doi: 10.1111/j.1365-263X.2011.01124.x. Epub 2011 Apr 6.
- Background: PubMed 17273178Ashkenazi M, Blumer S, Eli I. Post-operative pain and use of analgesic agents in children following intrasulcular anaesthesia and various operative procedures. Br Dent J. 2007 Mar 10;202(5):E13; discussion 276-7. doi: 10.1038/bdj.2007.81. Epub 2007 Feb 2.
- Background: PubMed 12605626Jurgens S, Warwick RS, Inglehearn PJ, Gooneratne DS. Pain relief for paediatric dental chair anaesthesia: current practice in a community dental clinic. Int J Paediatr Dent. 2003 Mar;13(2):93-7. doi: 10.1046/j.1365-263x.2003.00430.x.
- Background: PubMed 7617493Primosch RE, Nichols DL, Courts FJ. Comparison of preoperative ibuprofen, acetaminophen, and placebo administration on the parental report of postextraction pain in children. Pediatr Dent. 1995 May-Jun;17(3):187-91.
- Background: PubMed 3470325McGaw T, Raborn W, Grace M. Analgesics in pediatric dental surgery: relative efficacy of aluminum ibuprofen suspension and acetaminophen elixir. ASDC J Dent Child. 1987 Mar-Apr;54(2):106-9.
- Individual participant dataSharing planned: Undecided. Up to date, there is no decision about IPD sharing.
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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.
Nabih Raslan, Dr study chair
Latakia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acetaminophen and Ibuprofen in people with Local Anesthesia and Tooth Extraction, run by Latakia University at 1 site in Syria.
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 2 inclusion and 1 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 18 Jun 2019. 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 Syria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Assessment pain related to the injection of the local anesthesia using WBFS. (time frame: 30-60 seconds after injection of the local anesthesia.). The study lists 2 primary outcomes in all. 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 NCT03786029, which also lists 8 linked publications.
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 18 Jun 2019.