ORAL HEALTH EVIDENCE-BASED PRACTICE PROGRAM
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Title For Patients With Dental Pain, Combination Therapy With Ibuprofen And Acetaminophen Is More Effective In Producing Analgesia Than Monotherapy With Ibuprofen Alone
Clinical Question In patients with inflammatory pain, does the combination of ibuprofen and acetaminophen compared to ibuprofen alone produce greater analgesia?
Clinical Bottom Line Combination therapy with ibuprofen and acetaminophen produces greater analgesia than ibuprofen alone in patients with inflammatory pain.
Best Evidence (you may view more info by clicking on the PubMed ID link)
PubMed ID Author / Year Patient Group Study type
(level of evidence)
#1) 21257263Daniels/2011678 patients at least 16 years old with at least 3 impacted 3rd molars and post-extraction painRCT
Key resultsThese patients were divided into 5 treatment groups but only 3 groups were pertinent to the PICO question. Two groups received ibuprofen/acetaminophen (group A received two tablets of a single-tablet combination of ibuprofen 200mg/acetaminophen 500mg and group B received one tablet) while the third group (group C) received two tablets of ibuprofen 200mg/codeine 12.8mg. Drug efficacy was measured using SPRID (sum of the pain relief and intensity difference) over 12 hours follow up and SPRID values were analyzed with ANOVA (analysis of variance). Groups A, B, & C had least square means of 3.33, 2.71, & 2.65 respectively. Thus, group A’s combination (two tablets of ibuprofen 200mg/acetaminophen 500mg) was the most efficacious in providing analgesia. Comparing groups A & C had a difference of 0.67, p-value of 0.0001, and a 95% confidence interval of 0.33, 1.02. Comparing groups B & C had a difference of 0.06, p-value of 0.72, and a 95% confidence interval of -0.28, 0.4. These results show that 2 tablets of ibuprofen 200 mg/acetaminophen 500mg are significantly more effective in producing analgesia post-extraction than 2 tablets of ibuprofen 200mg/codeine 12.8 mg. Also, while the results show that 1 tablet of ibuprofen 200mg/acetaminophen 500mg is more effective than 2 tablets of ibuprofen 200mg/codeine 12.8 mg, the difference between these two treatments is not statistically significant.
#2) 20637958Mehlisch/2010735 patients at least 16 years old with at least 3 impacted 3rd molars and post-extraction painRCT
Key resultsPatients were divided into 8 treatment groups but only 4 groups were pertinent to the PICO question. Two groups received ibuprofen/acetaminophen: group A received ibuprofen 200 mg/acetaminophen 500 mg, and group B received ibuprofen 400 mg/acetaminophen 1000mg. Two groups received ibuprofen: group C received ibuprofen 200mg and group D received ibuprofen 400mg. Drug efficacy was measured using SPRID (sum of pain relief and intensity difference over 8 hours follow up. Comparing groups A and C had a least square means difference of 0.8 with a p-value of <0.001 and a 95% confidence interval of 0.4 to 1.21. Comparing groups B and D had a least square means difference of 0.47 with a p-value of 0.02 and a 95% confidence interval of 0.07 to 0.88. Comparing groups A and D had a least square means difference of 0.40 with a p-value of 0.054 and a 95% confidence interval of -0.01 to 0.81. These results show that combination therapy with ibuprofen/acetaminophen is more effective than ibuprofen alone in relieving post-extraction inflammatory pain.
#3) 15230906Menhinick/200457 patients with post-operative pain following non-surgical root canal therapyRCT
Key resultsPatients were divided into 3 treatment groups. Group A received ibuprofen 600mg/acetaminophen 1000mg, group B received ibuprofen 600mg, and group C received placebo. Drug efficacy was measured using the VAS (visual analogue scale). The mean of all VAS values over 8 hours with 95% confidence intervals were 3 (0-6) for group A and 17 (11-21) for group B. Comparing group A to group B there is a difference of 14 between mean VAS values with a p-value of 0.047. These results show that ibuprofen 600mg/acetaminophen 1000mg is more effective in producing analgesia following endodontic therapy than ibuprofen 600 mg.
Evidence Search (("Pain"[Mesh]) AND "Ibuprofen"[Mesh]) AND "Acetaminophen"[Mesh]
Comments on
The Evidence
All 3 studies were RCTs with groups similar at start, >80% completion rate, groups treated the same, adequate follow up, double blinding, adequate compliance, and unlikely recall bias. For the Daniels article, Daniels is an employee of the company whose clinics participated in the study. For the Mehlisch article, Dr. Mehlisch is a paid consultant of the company responsible for designing the study and writing the protocol. For the Menhinick article, there are no competing interests disclosed.
Applicability For patients with inflammatory pain after extraction or endodontic therapy, combination therapy with ibuprofen/acetaminophen is a better option than monotherapy with ibuprofen alone. Please note that acetaminophen is associated with increased risk for liver failure and therefore total daily dosage should not exceed 3g/day. In addition, these clinical trials covered only short-term use and therefore these recommendations should not be interpreted as supporting long-term administration of these two drugs.
Specialty/Discipline (Endodontics) (General Dentistry) (Oral Surgery) (Periodontics)
Keywords Ibuprofen, acetaminophen, endodontics, extraction, surgery, inflammatory pain
ID# 2379
Date of submission: 02/25/2013spacer
E-mail zhangmq@livemail.uthscsa.edu
Author Michael Zhang
Co-author(s)
Co-author(s) e-mail
Faculty mentor/Co-author Kenneth Hargreaves, DDS, PhD
Faculty mentor/Co-author e-mail hargreaves@uthscsa.edu
Basic Science Rationale
(Mechanisms that may account for and/or explain the clinical question, i.e. is the answer to the clinical question consistent with basic biological, physical and/or behavioral science principles, laws and research?)
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None available
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Comments on the CAT
(FOR PRACTICING DENTISTS' and/or FACULTY COMMENTS ON PUBLISHED CATs)
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