PMID- 24678099 OWN - NLM STAT- PubMed-not-MEDLINE DCOM- 20140328 LR - 20211021 IS - 0011-393X (Print) IS - 0011-393X (Linking) VI - 67 IP - 4 DP - 2006 Jul TI - Prospective, randomized, open-label, pilot clinical trial comparing the effects of dexamethasone coadministered with diclofenac potassium or acetaminophen and diclofenac potassium monotherapy after third-molar extraction in adults. PG - 229-40 LID - 10.1016/j.curtheres.2006.07.001 [doi] AB - BACKGROUND: Patients who experience pain, swelling, and trismus after third-molar extraction are reported to experience a 3-fold higher rate of adverse effects (AEs) on quality of life compared with those who are asymptomatic after this surgery. Therefore, investigators emphasize the necessity for better control of this triad of sequelae. Steroids can reduce the risk for physiologic processes of inflammation, thereby suppressing the development of inflammation. OBJECTIVE: The aim of this study was to compare the effects of dexamethasone 8 mg IM and diclofenac potassium (K) 50 mg PO, dexamethasone 8 mg IM and acetaminophen 1000 mg PO, and monotherapy with diclofenac K 50 mg PO on postoperative pain, swelling, and trismus after surgical removal of third molars. METHODS: This prospective, randomized, open-label pilot study was conducted at the Department of Oral and Maxillofacial Surgery, Lagos University Teaching Hospital, Lagos, Nigeria. Patients were randomly allocated to 1 of 3 treatment groups: concomitant treatment with dexamethasone 8 mg IM and diclofenac K 50 mg PO or acetaminophen 1000 mg PO, or monotherapy with diclofenac K 50 mg PO. Overall analgesic efficacy of the drug combinations was assessed for 7 days postoperatively using a 4-point categorical pain-intensity rating scale (0 = no pain; 1 = mild pain; 2 = moderate pain; and 3 = severe pain). Facial swelling was measured in 1 dimension on days 1, 2, and 7 after surgery using a tape measure placed from the tip of the tragus, to gonion, to the tip of the contralateral tragus, and trismus was assessed using interincisal mouth-opening ability, measured using a vernier-calibrated caliper on postoperative days 1, 2, and 7. Tolerability was assessed using direct questioning of the patients at follow-up visits. RESULTS: A total of 150 patients (50 per treatment group) were included in the analysis (76 women, 74 men; mean [SD] age, 26.8 [5.04] years [range, 18-45 years]; 100% Nigerian). The proportion of patients reporting no pain on the pain-intensity rating scale was significantly higher in the group receiving dexamethasone and diclofenac K compared with that in the groups receiving dexamethasone and acetaminophen or diclofenac K monotherapy (44% vs 22% and 24%, respectively; both, P < 0.05). Facial swelling was significantly less with dexamethasone and diclofenac K or dexamethasone and acetaminophen compared with diclofenac K alone (day 1: P = 0.013 and P = 0.011, respectively; day 2: P = 0.002 and P = 0.004, respectively). However, trismus relief was statistically similar between the 3 treatment groups on postoperative days 1 and 2. No AEs or complications were recorded. CONCLUSION: In this open-label pilot study, concomitant treatment with dexamethasone and diclofenac K provided significant relief of postsurgical pain and swelling compared with dexamethasone and acetaminophen or monotherapy with diclofenac K after third-molar extraction in these patients. FAU - Bamgbose, Babatunde Olamide AU - Bamgbose BO AD - Department of Oral and Maxillofacial Surgery, Lagos University Teaching Hospital, Lagos, Nigeria. FAU - Akinwande, Jelili Adisa AU - Akinwande JA AD - Department of Oral and Maxillofacial Surgery, College of Medicine, University of Lagos, Lagos, Nigeria. FAU - Adeyemo, Wasiu Lanre AU - Adeyemo WL AD - Department of Oral and Maxillofacial Surgery, College of Medicine, University of Lagos, Lagos, Nigeria. FAU - Ladeinde, Akinola Ladipo AU - Ladeinde AL AD - Department of Oral and Maxillofacial Surgery, College of Medicine, University of Lagos, Lagos, Nigeria. FAU - Arotiba, Godwin Toyin AU - Arotiba GT AD - Department of Oral and Maxillofacial Surgery, College of Medicine, University of Lagos, Lagos, Nigeria. FAU - Ogunlewe, Mobolanle Olugbemiga AU - Ogunlewe MO AD - Department of Oral and Maxillofacial Surgery, College of Medicine, University of Lagos, Lagos, Nigeria. LA - eng PT - Journal Article PL - United States TA - Curr Ther Res Clin Exp JT - Current therapeutic research, clinical and experimental JID - 0372621 PMC - PMC3965982 OTO - NOTNLM OT - acetaminophen OT - dexamethasone OT - diclofenac potassium OT - third-molar extraction EDAT- 2006/07/01 00:00 MHDA- 2006/07/01 00:01 PMCR- 2006/07/01 CRDT- 2014/03/29 06:00 PHST- 2006/05/30 00:00 [accepted] PHST- 2014/03/29 06:00 [entrez] PHST- 2006/07/01 00:00 [pubmed] PHST- 2006/07/01 00:01 [medline] PHST- 2006/07/01 00:00 [pmc-release] AID - S0011-393X(06)00055-5 [pii] AID - 10.1016/j.curtheres.2006.07.001 [doi] PST - ppublish SO - Curr Ther Res Clin Exp. 2006 Jul;67(4):229-40. doi: 10.1016/j.curtheres.2006.07.001.