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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) 20685496 | Mehlisch/2010 | 234 patients post extraction of impacted molars | Randomized controlled trial | | Key results | Group 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) 20637958 | Mehlisch/2010 | 678 patients post extraction of impacted third molars | Randomized controlled trial | | Key results | This 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: |
04/19/2016 |
| 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 |
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?) |
post a rationale |
| None available | |
|
Comments and Evidence-Based Updates on the CAT
(FOR PRACTICING DENTISTS', FACULTY, RESIDENTS and/or STUDENTS COMMENTS ON PUBLISHED CATs) |
post a comment |
| None available | |
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