A randomized trial of dalteparin compared with ibuprofen for the treatment of superficial thrombophlebitis

J Thromb Haemost. 2012 May;10(5):833-9. doi: 10.1111/j.1538-7836.2012.04669.x.

Abstract

Background: Superficial thrombophlebitis can produce pain and result in a deep vein thrombosis (DVT) if not treated. Conservative therapies including prescription of non-steroidal anti-inflammatory drugs (NSAID) and heat have been standard care. Recently, studies have been published reporting efficacy and safety of low-molecular-weight heparin for the treatment of superficial thrombophlebitis. However, there are few comparative trials to conservative therapy. We studied the effectiveness and safety of treatment with dalteparin compared with ibuprofen in patients with confirmed superficial thrombophlebitis.

Methods: Consecutive patients were randomized to receive daily dalteparin vs. ibuprofen three times daily for up to 14 days. The primary outcome measure was the incidence of extension of thrombus or new symptomatic venous thromboembolism during the 14-day and 3-month follow-up period. The secondary outcome was a reduction in pain. The outcome measure of safety was the incidence of major and minor bleeding.

Results: Of 302 consecutive patients screened, 72 were enrolled. Four patients receiving ibuprofen compared with no patients receiving dalteparin had thrombus extension at 14 days (P = 0.05), however, there was no difference in thrombus extension at 3 months. Both treatments significantly reduced pain. There were no episodes of major or minor bleeding during the treatment period.

Conclusions: Dalteparin is superior to the NSAID ibuprofen in preventing extension of superficial thrombophlebitis during the 14-day treatment period with similar relief of pain and no increase in bleeding. However, questions concerning the optimal treatment duration should be explored in future trials.

Trial registration: ClinicalTrials.gov NCT00264381.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Inflammatory Agents, Non-Steroidal / administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal / adverse effects
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Dalteparin / administration & dosage
  • Dalteparin / adverse effects
  • Dalteparin / therapeutic use*
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Fibrinolytic Agents / administration & dosage
  • Fibrinolytic Agents / adverse effects
  • Fibrinolytic Agents / therapeutic use*
  • Hemorrhage / chemically induced
  • Humans
  • Ibuprofen / administration & dosage
  • Ibuprofen / adverse effects
  • Ibuprofen / therapeutic use*
  • Injections, Subcutaneous
  • Male
  • Middle Aged
  • Oklahoma
  • Pain / etiology
  • Pain / prevention & control
  • Risk Assessment
  • Risk Factors
  • Thrombophlebitis / complications
  • Thrombophlebitis / drug therapy*
  • Time Factors
  • Treatment Outcome
  • Venous Thromboembolism / etiology
  • Venous Thromboembolism / prevention & control
  • Young Adult

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Fibrinolytic Agents
  • Dalteparin
  • Ibuprofen

Associated data

  • ClinicalTrials.gov/NCT00264381