Efficacy of Different Drugs to Control Post Root Canal Treatment Pain
Primary Purpose
Pain, Postoperative Pain, Irreversible Pulpitis
Status
Completed
Phase
Phase 2
Locations
Sudan
Study Type
Interventional
Intervention
Root Canal Treatment
Paracetamol
Ibuprofen
Mefenamic acid
Diclofenac
Sponsored by
About this trial
This is an interventional treatment trial for Pain
Eligibility Criteria
Inclusion Criteria:
- Patient reported spontaneous pain moderate to severe, ranging from 50 to 100 mm on a VAS (0-100 mm);
- Adult patients presented for emergency endodontic treatment with a symptomatic maxillary or mandibular tooth (anterior and premolar) with a pulpal diagnosis of Irreversible pulpitis and normal periapex.
- Patient choose to have root canal treatment for pain of endodontic origin.
- The patient presented with American Society of Anesthesiologists (ASA) I or II medical history (ASA 1963).
- The patient had read and thoroughly understood the pain score level sheet
Exclusion Criteria:
- Patients below 18 years of age;
- Analgesic taken within the last 4 hours;
- History of allergy to NSAIDs, paracetamol or local anaesthetics;
- History of uncontrolled systemic disease [gastrointestinal (GI) disorders, oesophageal reflux, active asthma, decreased hepatic function, haemorrhagic disorders, or poorly controlled diabetes mellitus].
- Patients currently taking opioids, monoamine oxidase inhibitors, tricyclic antidepresssants, carbamazepine, diuretics, or anticoagulants;
- There was history of opioid addiction or abuse; and
- Pregnant or nursing female patients.
Sites / Locations
- University of Khartoum, Faculty of Dentistry,
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
Group I
Group II
Group III
Group IV
Group V
Arm Description
paracetamol 1000mg
ibuprofen 600mg + paracetamol 1000mg,
Mefenamic acid 500mg + Paracetamol 1000mg
Diclofenac K 50mg + paracetamol 1000 mg
No medication
Outcomes
Primary Outcome Measures
Efficacy of different Drugs to Control Post Root Canal Treatment Pain as measured by Visual Analogue Scale.
The patients were asked to make entries on the VAS (numerical score) every hour for the first 4 hours after taking the medication and then every 2 hours following that; a total of six entries over 8 hours.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02417337
Brief Title
Efficacy of Different Drugs to Control Post Root Canal Treatment Pain
Official Title
Efficacy of Pain Control Following Root Canal Treatment Using Paracetamol Alone and in Combination With Three Different Non-Steroidal Anti-Inflammatory Analgesics
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Khartoum
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Root canal therapy will ideally eliminate post-endodontic pain but occasionally analgesics are needed to diminish the pain [1]. Development of pain after completion of root canal treatment may undermine patients' confidence in the procedure and the clinician [2]. Non-steroidal anti-inflammatory drugs are one of the most frequently taken analgesic medications for dental pain. Their popularity attributed to their efficacy in relieving pain and fever and low side effect profile at therapeutic doses [3]. Mono-therapy analgesic has a low effect on dental pain. Improvement was performance by combining analgesics with different mechanisms of action without raising any adverse effects [4], was effective in controlling moderate to severe pain. The combination of a non-steroidal anti-inflammatory drug (NSAID) and paracetamol has shown additive analgesia for treating dental pain in several studies [5,6]. Endodontic treatment with a lower prevalence of postoperative pain is usually the treatment of choice. There have been no controlled dental studies evaluating the additive effects of combining a non-steroidal anti-inflammatory drug with paracetamol. Breivik et al [6] & Menhinick et al [7] found that a combination of acetaminophen and ibuprofen was more effective than ibuprofen alone in managing postoperative pain. Aim of the present study, to evaluate the efficacy of the paracetamol when used alone and in combinations with three groups of drugs to control postoperative endodontic pain.
Detailed Description
Background: Management of pain is challenging part of dental treatment, sometimes pain is a major postoperative symptom after many dental procedures especially for endodontics. The aim of the present randomized clinical trial was to investigate the efficacy of using paracetamol alone and three combinations of non-steroidal anti-inflammatory drugs with paracetamol, to control postoperative endodontics pain.
Methodology: 185 patients who had anterior or premolar teeth with irreversible pulpitis without any signs and symptoms of apical periodontitis and with moderate to severe pain. Patients were divided by allocation randomization into five groups. Four experimental groups receiving different medication; group I (single dose of paracetamol); group II (ibuprofen / paracetamol); group III (diclofenac k / paracetamol), group IV (mefenamic acid /paracetamol) and group V (no medication group). The groups received the medication after the first appointment where the pulp removed, and canals fully prepared. Pain intensity was scored based on 10-point VAS before and after treatment for up to 8 hours postoperatively. Sign test used for comparing pain score before and after treatment. This randomized control clinical trial was conducted on patients who were considered potential candidates if they had moderate to severe spontaneous pain of odontogenic origin (40-100 mm on a visual analogue scale, VAS). Patients were selected from those attending the Conservative dentistry clinics in both the University and the Teaching Hospital Emergency Clinic.
The medications were prepared in the laboratories of faculty of Pharmacy. Four groups of medications were prepared as follows; Group I: paracetamol 1000mg Group II: ibuprofen 600mg + paracetamol 1000mg, Group III: Mefenamic acid 500mg + Paracetamol 1000mg Group IV: Diclofenac K 50mg + paracetamol 1000 mg
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative Pain, Irreversible Pulpitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
170 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I
Arm Type
Active Comparator
Arm Description
paracetamol 1000mg
Arm Title
Group II
Arm Type
Experimental
Arm Description
ibuprofen 600mg + paracetamol 1000mg,
Arm Title
Group III
Arm Type
Experimental
Arm Description
Mefenamic acid 500mg + Paracetamol 1000mg
Arm Title
Group IV
Arm Type
Experimental
Arm Description
Diclofenac K 50mg + paracetamol 1000 mg
Arm Title
Group V
Arm Type
Placebo Comparator
Arm Description
No medication
Intervention Type
Procedure
Intervention Name(s)
Root Canal Treatment
Other Intervention Name(s)
Endodontic treatment
Intervention Description
A standardized endodontic procedures performed.
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Type
Drug
Intervention Name(s)
Mefenamic acid
Intervention Type
Drug
Intervention Name(s)
Diclofenac
Primary Outcome Measure Information:
Title
Efficacy of different Drugs to Control Post Root Canal Treatment Pain as measured by Visual Analogue Scale.
Description
The patients were asked to make entries on the VAS (numerical score) every hour for the first 4 hours after taking the medication and then every 2 hours following that; a total of six entries over 8 hours.
Time Frame
8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient reported spontaneous pain moderate to severe, ranging from 50 to 100 mm on a VAS (0-100 mm);
Adult patients presented for emergency endodontic treatment with a symptomatic maxillary or mandibular tooth (anterior and premolar) with a pulpal diagnosis of Irreversible pulpitis and normal periapex.
Patient choose to have root canal treatment for pain of endodontic origin.
The patient presented with American Society of Anesthesiologists (ASA) I or II medical history (ASA 1963).
The patient had read and thoroughly understood the pain score level sheet
Exclusion Criteria:
Patients below 18 years of age;
Analgesic taken within the last 4 hours;
History of allergy to NSAIDs, paracetamol or local anaesthetics;
History of uncontrolled systemic disease [gastrointestinal (GI) disorders, oesophageal reflux, active asthma, decreased hepatic function, haemorrhagic disorders, or poorly controlled diabetes mellitus].
Patients currently taking opioids, monoamine oxidase inhibitors, tricyclic antidepresssants, carbamazepine, diuretics, or anticoagulants;
There was history of opioid addiction or abuse; and
Pregnant or nursing female patients.
Facility Information:
Facility Name
University of Khartoum, Faculty of Dentistry,
City
Khartoum
ZIP/Postal Code
111-11
Country
Sudan
12. IPD Sharing Statement
Citations:
PubMed Identifier
17437870
Citation
Owatz CB, Khan AA, Schindler WG, Schwartz SA, Keiser K, Hargreaves KM. The incidence of mechanical allodynia in patients with irreversible pulpitis. J Endod. 2007 May;33(5):552-6. doi: 10.1016/j.joen.2007.01.023. Epub 2007 Mar 6.
Results Reference
result
PubMed Identifier
9594474
Citation
Albashaireh ZS, Alnegrish AS. Postobturation pain after single- and multiple-visit endodontic therapy. A prospective study. J Dent. 1998 Mar;26(3):227-32. doi: 10.1016/s0300-5712(97)00006-7.
Results Reference
result
PubMed Identifier
18498882
Citation
Attar S, Bowles WR, Baisden MK, Hodges JS, McClanahan SB. Evaluation of pretreatment analgesia and endodontic treatment for postoperative endodontic pain. J Endod. 2008 Jun;34(6):652-5. doi: 10.1016/j.joen.2008.02.017. Epub 2008 Apr 2.
Results Reference
result
PubMed Identifier
12148679
Citation
Mehlisch DR. The efficacy of combination analgesic therapy in relieving dental pain. J Am Dent Assoc. 2002 Jul;133(7):861-71. doi: 10.14219/jada.archive.2002.0300.
Results Reference
result
PubMed Identifier
10613619
Citation
Breivik EK, Barkvoll P, Skovlund E. Combining diclofenac with acetaminophen or acetaminophen-codeine after oral surgery: a randomized, double-blind single-dose study. Clin Pharmacol Ther. 1999 Dec;66(6):625-35. doi: 10.1053/cp.1999.v66.103629001.
Results Reference
result
Citation
Keiser K, Hargreaves K.Building effective strategies for the management of endodontic pain. Endodontic Topics, Volume 3, Issue 1, pages 93-105, November 2002
Results Reference
result
PubMed Identifier
15230906
Citation
Menhinick KA, Gutmann JL, Regan JD, Taylor SE, Buschang PH. The efficacy of pain control following nonsurgical root canal treatment using ibuprofen or a combination of ibuprofen and acetaminophen in a randomized, double-blind, placebo-controlled study. Int Endod J. 2004 Aug;37(8):531-41. doi: 10.1111/j.1365-2591.2004.00836.x.
Results Reference
result
PubMed Identifier
27080115
Citation
Elzaki WM, Abubakr NH, Ziada HM, Ibrahim YE. Double-blind Randomized Placebo-controlled Clinical Trial of Efficiency of Nonsteroidal Anti-inflammatory Drugs in the Control of Post-endodontic Pain. J Endod. 2016 Jun;42(6):835-42. doi: 10.1016/j.joen.2016.02.014. Epub 2016 Apr 12.
Results Reference
derived
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Efficacy of Different Drugs to Control Post Root Canal Treatment Pain
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