ORAL HEALTH EVIDENCE-BASED PRACTICE PROGRAM
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Title 400 mg Ibuprofen/1000 mg Acetaminophen (Paracetamol) Is Suggested Effective Dosage for Ibuprofen/Acetaminophen Combination Therapy in Postoperative Pain Reduction
Clinical Question In patients receiving acetaminophen (paracetamol) and ibuprofen combination therapy, what is the effective dosage to relieve postoperative pain?
Clinical Bottom Line For patients with postoperative pain, 400 mg ibuprofen/1000 mg acetaminophen (paracetamol) is the suggested effective dosage for short-term pain management.
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) 20685496Mehlisch/2010234 patients post extraction of impacted molarsRandomized controlled trial
Key resultsGroup treated postoperatively with ibuprofen 400 mg/paracetamol 1000 mg had significantly better mean scores for summed pain relief and intensity differences from 0 to 8 hours (SPRID8) compared with ibuprofen alone (P < 0.001) & compared to the group given ibuprofen 200 mg/paracetamol 500 mg (P = 0.02). The group taking the ibuprofen 200 mg/paracetamol 500 mg dosage achieved significantly better mean SPRID8 scores than paracetamol alone (P = 0.03), but not ibuprofen alone (P = NS). Ibuprofen 400 mg/paracetamol 1000 mg was shown to be associated with significantly better scores than any single-agent therapy for total pain relief (TOTPAR), sum of pain intensity differences (SPID) from 0 to 8 hours, and SPID VAS (visual affective score) at all time intervals and for SPRID from 4 to 6 hours (all, P < 0.001). All of the active treatments performed better than the placebo group for all efficacy end-points. Adverse effects were similar for all treatments and included nausea (26.1%), vomiting (18.8%), headache (10.3%), dizziness (8.1%). Note: regimen suggested for short-term therapy; manufacturers have suggested a total daily dosage of acetaminophen of no more than 3 g.
#2) 20637958Mehlisch/2010678 patients post extraction of impacted third molarsRandomized controlled trial
Key resultsThis was a comparison of single tablet, fixed dose combinations (FDC) of ibuprofen/paracetamol (doses of 100 mg/250 mg, 200 mg/500 mg, and 400 mg/1000 mg) with comparable doses of ibuprofen (200 or 400 mg) & paracetamol (500 or 1000 mg) monotherapy, and placebo in the 8 hours post-extraction of 3 to 4 impacted third molars (stage 1) and with placebo over the next 72 hours (stage 2). In the monotherapy groups, rescue medication was required by: 53 of 73 (72.6%) = placebo, 29 of 75 (38.7%) = ibuprofen 200-mg, 21 of 74 (28.4%) = ibuprofen 400-mg, 56 of 76 (73.7%) = paracetamol 500-mg, and 51 of 74 (68.9%) = paracetamol1000-mg. For the FDC groups, rescue medication was required by: 27 of 71 (38.0%) = ibuprofen 100-mg/paracetamol 250-mg, 40 of 143 (28.0%) = ibuprofen 200-mg/paracetamol 500-mg, and 32 of 149 (21.5%) = ibuprofen 400-mg/paracetamol 1000-mg.
Evidence Search ((((((((((acetaminophen) OR paracetamol) AND ibuprofen) AND post operative pain) AND Clinical Trial[ptyp] AND Humans[Mesh])) AND combination) AND Clinical Trial[ptyp] AND Humans[Mesh])) AND dosage) AND Clinical Trial[ptyp] AND Humans[Mesh]
Comments on
The Evidence
Validity: Both studies were randomized controlled trials involving patients reporting postoperative pain after surgical extraction of impacted molars. All patients were randomized to groups and were followed appropriately for 8 – 72 hours after the surgical procedure to measure their summed pain relief and pain intensity difference after receiving the study medications or placebo. The studies were all double-blinded, with participants receiving medications identical in appearance although differing in composition. The study participants demonstrated adequate compliance and their keeping of a pain diary during the study period helped to minimize recall bias. There were no competing interests in these studies. Perspective: These studies only compared combination non-opioid analgesic therapy to monotherapy with non-opioid analgesics. It would be beneficial to study dosages of combination non-opioid analgesics compared to commonly used opioid analgesics to assess minimum effective dosages. Assessing the side-effect profile on patients while comparing these therapies could also be useful.
Applicability These studies were conducted on patients that could be seen in most any dental setting where post-operative pain is a treatment consideration. As an alternative to opioid analgesics, non-opioid combination drug therapy is feasible in all practice settings. The use of non-opioid combination therapy is an attractive option for relief of post-operative pain as it decreases cost of medication & there is no risk of dependence as with opioids.
Specialty/Discipline (Endodontics) (General Dentistry) (Oral Surgery) (Periodontics)
Keywords Acetaminophen, ibuprofen, paracetamol, combination therapy, post-operative pain, dental pain.
ID# 2994
Date of submission: 04/19/2016spacer
E-mail keyl@livemail.uthscsa.edu
Author Lacey Brooke Key, RDH
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
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