ORAL HEALTH EVIDENCE-BASED PRACTICE PROGRAM
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Title Tramadol/Acetaminophen Tablets Provide Rapid, Effective, and Dose-Dependent Analgesia Following Dental Surgery
Clinical Question Following dental surgery, does Tramadol provide adequate analgesia when compared to hydrocodone/APAP or codeine/APAP combination drug preparations?
Clinical Bottom Line Tramadol/Acetaminophen 75/650mg tablets provide effective, rapid (< or = 34mins), dose-dependent analgesia following dental surgery. The onset and efficacy of analgesia of Tr/APAP is comparable to that of Co/APAP/Ibuprofen 20/500/400mg while two Tr/APAP tablets provides analgesia comparable to that provided by HC/APAP 10/650mg with better tolerability.
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) 15336468Jung/2004128 healthy adults undergoing extraction of > or = 1 impacted 3rd molarsRandomized Controlled Trial
Key resultsTr/APAP 75/650mg and Co/APAP/Ibuprofen 20/500/400mg mean total pain relief and the sum of pain intensity difference were similar 0-4 hrs after dosing; however, between 4-6 hrs, Co/Ac/Ib was associated with significant differences in both variables compared to Tr/Ac (P<0.05). The mean pain intensity was significantly greater with Co/Ac/Ib at 4-6 hrs. Patients assessed treatment as good or better with Co/Ac/Ib compared to Tr/Ac (P<0.05). “The safety profile of Tr/APAP was comparable to that of Co/APAP/Ib.”
#2) 12117085Fricke/2002200 adults undergoing extraction of > = 2 impacted 3rd molars.Randomized Controlled Trial
Key resultsTr/APAP 75/650mg and HC/APAP 10/650mg were statistically superior to placebo in total pain relief (TOTPAR), sum of pain intensity differences (SPID) and sum of pain relief and pain intensity differences (SPRID) (P < or = 0.024). There is a statistically significant dose response with Tr/APAP (2 tabs > 1 tabs > placebo) for TOTPAR, SPID, and SPRID (P < or = 0.018). The median time to onset of pain relief was approximately 34 mins for 2 Tr/APAP tablets and 25.4mins for HC/APAP. The 2 Tr/APAP tablets provided the comparable efficacy to 1 HC/APAP tablet. Median time to remedication was 169 mins with Tr/APAP 75/650mg and 204 mins with HC/APAP; however, duration of pain relief was not significantly different between these two groups.
Evidence Search "Tramadol"[Mesh] AND "Codeine"[Mesh] AND (Meta-Analysis[ptyp] OR systematic[sb] OR Randomized Controlled Trial[ptyp])
Comments on
The Evidence
Validity: Jung et. al. (2004) conducted a RCT and Fricke et. al. (2002) conducted a double-blind RCT comparing Tramadol/Acetaminophen to Codeine/APAP/Ib or Hydrocodone/APAP respectively in patients experiencing postoperative pain following extractions of 1 or more impacted 3rd molars. Both articles reported that groups were similar at the start of the study and were treated the same throughout experiencing greater than 80% completion rate by the selected participants in the study. They reported adequate follow-up and compliance of the patients with recall bias being unlikely and no statement of competing interests. Perspective: While these two articles demonstrate that Tramadol provides adequate analgesia following dental surgery, other factors must be taken into consideration such as dependence, side effects, and drug-drug interactions when prescribing Tramadol to a patient.
Applicability For patients experience postoperative pain following dental surgery, Tramadol/APAP provides rapid and effective analgesia for acute postoperative pain with great tolerability. However, it is better to try and follow normal pain management via prescribing Ibuprofen/APAP rather than narcotics to manage dental pain when appropriate. 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 should not be interpreted as supporting long-term administration of Tramadol/APAP.
Specialty/Discipline (General Dentistry) (Oral Surgery) (Periodontics)
Keywords Tramadol, Codeine, Hydrocodone, Acetaminophen, Dental Pain, Oral Surgery, Surgery, Extraction
ID# 2725
Date of submission: 05/05/2014spacer
E-mail thielj@livemail.uthscsa.edu
Author Joshua Thiel
Co-author(s)
Co-author(s) e-mail
Faculty mentor/Co-author Jack Vizuete, DDS
Faculty mentor/Co-author e-mail vizuetej@uthscsa.edu
Basic Science Rationale
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