Pre-emptive Analgesic Administration in Primary Tooth Extraction
NCT ID: NCT03786029
Last Updated: 2019-06-18
Study Results
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Basic Information
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COMPLETED
PHASE2/PHASE3
66 participants
INTERVENTIONAL
2019-04-01
2019-06-10
Brief Summary
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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.
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Detailed Description
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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:
1. Acetaminophen syrup: 160mg/5ml
2. Placebo solution
3. Ibuprofen suspension: 100mg/5ml
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A (Acetaminophen)
22 children will receive 320mg (10ml) 30 minutes before the local anesthesia injection.
Acetaminophen
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.
B (Placebo)
22 children will receive 10ml 30 minutes before the local anesthesia injection.
Placebo
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.
C (Ibuprofen)
22 children will receive 200mg (10ml) 30 minutes before the local anesthesia injection.
Ibuprofen
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.
Interventions
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Acetaminophen
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.
Placebo
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.
Ibuprofen
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\-
Exclusion Criteria
6 Years
8 Years
ALL
Yes
Sponsors
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Tishreen University
OTHER
Responsible Party
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Nabih Raslan
Principal Investigator
Principal Investigators
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Nabih Raslan, Dr
Role: STUDY_CHAIR
Tishreen University
Locations
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Tishreen University
Latakia, , Syria
Countries
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References
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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.
Pozos-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.
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.
Baygin 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.
Ashkenazi 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.
Jurgens 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.
Primosch 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.
McGaw 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.
Other Identifiers
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Tishreen - Pre-emptive
Identifier Type: -
Identifier Source: org_study_id
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