Clinical trial NCT03786029: Pre-emptive Analgesic Administration in Primary Tooth Extraction
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Local Anesthesia
Tooth Extraction
Keywords: Pre-emptive administration
Analgesic
Tooth extraction
Lead sponsor: Tishreen University
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 66
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Blinded, randomized placebo-controlled trial, comparing three groups.
Primary purpose: TREATMENT

Brief 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.

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:

1. Acetaminophen syrup: 160mg/5ml
2. Placebo solution
3. Ibuprofen suspension: 100mg/5ml

Eligibility criteria: Inclusion Criteria:

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.

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Exclusion Criteria:

Teeth with advanced root resorption (a third of the root at least)

Primary outcomes:
measure: Assessment pain related to the injection of the local anesthesia using WBFS.
timeFrame: 30-60 seconds after injection of the local anesthesia.
measure: Post operative pain assessment using WBFS.
timeFrame: 10 minutes - 6 hours after the extraction.
Secondary outcomes:
measure: Evaluate the parents' satisfaction using Likert fifth scale.
timeFrame: 6 hours after extraction.
Other outcomes:
Locations:
city: Latakia
country: Syrian Arab Republic
facility: Tishreen University
Study officials:
affiliation: Tishreen University
name: Nabih Raslan, Dr
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.