PMID- 29056859
OWN - NLM
STAT- MEDLINE
DCOM- 20180511
LR  - 20181113
IS  - 1918-1523 (Electronic)
IS  - 1203-6765 (Print)
IS  - 1203-6765 (Linking)
VI  - 2017
DP  - 2017
TI  - Efficacy and Safety of Transdermal Buprenorphine versus Oral 
      Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after 
      Spinal Surgery.
PG  - 2071494
LID - 10.1155/2017/2071494 [doi]
LID - 2071494
AB  - PURPOSE: Control of persistent pain following spinal surgery is an unmet clinical 
      need. This study compared the efficacy and safety of buprenorphine transdermal 
      system (BTDS) to oral tramadol/acetaminophen (TA) in Korean patients with 
      persistent, moderate pain following spinal surgery. METHODS: Open-label, 
      interventional, randomized multicenter study. Adults with persistent 
      postoperative pain (Numeric Rating Scale [NRS] >/= 4 at 14-90 days postsurgery) 
      were enrolled. Patients received once-weekly BTDS (n = 47; 5 mug/h titrated to 
      20 mug/h) or twice-daily TA (n = 40; tramadol 37.5 mg/acetaminophen 325 mg, one 
      tablet titrated to 4 tablets) for 6 weeks. The study compared pain reduction with 
      BTDS versus TA at week 6. Quality of life (QoL), treatment satisfaction, 
      medication compliance, and adverse events (AEs) were assessed. FINDINGS: At week 
      6, both groups reported significant pain reduction (mean NRS change: BTDS -2.02; 
      TA -2.76, both P < 0.0001) and improved QoL (mean EQ-5D index change: BTDS 0.10; 
      TA 0.19, both P < 0.05). The BTDS group achieved better medication compliance 
      (97.8% versus 91.0%). Incidence of AEs (26.1% versus 20.0%) and adverse drug 
      reactions (20.3% versus 16.9%) were comparable between groups. IMPLICATIONS: For 
      patients with persistent pain following spinal surgery, BTDS is an alternative to 
      TA for reducing pain and supports medication compliance. This trial is registered 
      with Clinicaltrials.gov: NCT01983111.
FAU - Lee, Jae Hyup
AU  - Lee JH
AUID- ORCID: 0000-0002-2141-0266
AD  - Department of Orthopedic Surgery, Seoul National University College of Medicine, 
      SMG-SNU Boramae Medical Center, Seoul, Republic of Korea.
FAU - Kim, Jin-Hyok
AU  - Kim JH
AUID- ORCID: 0000-0002-7276-7994
AD  - Department of Orthopedic Surgery, Sanggye Paik Hospital, Seoul, Republic of 
      Korea.
FAU - Kim, Jin-Hwan
AU  - Kim JH
AD  - Department of Orthopedic Surgery, Ilsan Paik Hospital, Gyeonggi-do, Republic of 
      Korea.
FAU - Kim, Hak-Sun
AU  - Kim HS
AD  - Department of Orthopedic Surgery, Gangnam Severance Hospital, Yonsei University, 
      Seoul, Republic of Korea.
FAU - Min, Woo-Kie
AU  - Min WK
AD  - Department of Orthopedic Surgery, Kyungpook National University Hospital, Daegu, 
      Republic of Korea.
FAU - Park, Ye-Soo
AU  - Park YS
AD  - Department of Orthopedic Surgery, Guri Hospital, Hanyang University College of 
      Medicine, Gyeonggi-do, Republic of Korea.
FAU - Lee, Kyu-Yeol
AU  - Lee KY
AD  - Department of Orthopedic Surgery, Dong-A University Hospital, Busan, Republic of 
      Korea.
FAU - Lee, Jung-Hee
AU  - Lee JH
AD  - Department of Orthopedic Surgery, Graduate School, College of Medicine, Kyung Hee 
      University, Seoul, Republic of Korea.
LA  - eng
SI  - ClinicalTrials.gov/NCT01983111
PT  - Clinical Trial, Phase IV
PT  - Equivalence Trial
PT  - Journal Article
PT  - Multicenter Study
DEP - 20170913
PL  - United States
TA  - Pain Res Manag
JT  - Pain research & management
JID - 9612504
RN  - 0 (Analgesics, Opioid)
RN  - 362O9ITL9D (Acetaminophen)
RN  - 39J1LGJ30J (Tramadol)
RN  - 40D3SCR4GZ (Buprenorphine)
SB  - IM
MH  - Acetaminophen/administration & dosage/*therapeutic use
MH  - Administration, Cutaneous
MH  - Aged
MH  - Analgesics, Opioid/administration & dosage/therapeutic use
MH  - Buprenorphine/administration & dosage/*therapeutic use
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pain, Postoperative/*drug therapy
MH  - Quality of Life
MH  - Spine/*surgery
MH  - Tramadol/administration & dosage/*therapeutic use
PMC - PMC5615987
EDAT- 2017/10/24 06:00
MHDA- 2018/05/12 06:00
PMCR- 2017/01/01
CRDT- 2017/10/24 06:00
PHST- 2017/05/17 00:00 [received]
PHST- 2017/08/07 00:00 [accepted]
PHST- 2017/10/24 06:00 [entrez]
PHST- 2017/10/24 06:00 [pubmed]
PHST- 2018/05/12 06:00 [medline]
PHST- 2017/01/01 00:00 [pmc-release]
AID - 10.1155/2017/2071494 [doi]
PST - ppublish
SO  - Pain Res Manag. 2017;2017:2071494. doi: 10.1155/2017/2071494. Epub 2017 Sep 13.