A Multicenter Clinical Study on Treating PostDural Puncture Headache with an Intravenous Injection of Aminophylline

Abstract

Background: Post-dural puncture headache (PDPH) is the most common complication of lumbar puncture. Aminophylline has been reported to be effective in the prevention of PDPH in some clinical studies, but its efficacy for the treatment of PDPH has been unproven. Objective: To evaluate the efficacy and safety of an intravenous (IV) injection of aminophylline on PDPH. Study Design: The study was a multicenter, open-label study to assess the effectiveness and safety of aminophylline on PDPH. Setting: The First Affiliated Hospital of Zhengzhou University, The Fifth Affiliated Hospital of Zhengzhou University, and Henan Province Hospital of Traditional Chinese Medicine. Methods: Thirty-two PDPH patients received an IV injection of aminophylline. The primary and secondary endpoints were the degree of headache and the patient’s overall response to the treatment, respectively. Treatment safety was evaluated based on the occurrence of adverse reactions. Results: Thirty-one patients completed the study. Before the initial aminophylline administration, the visual analog scale (VAS) score was 7.72 ± 1.65. The VAS scores at 30 minutes, one hour, 8 hours, one day, and 2 days post-treatment were 4.84 ± 2.53, 3.53 ± 2.06, 2.38 ± 1.96, 1.44 ± 1.87, and 0.81 ± 1.79, respectively, and were statistically significantly different (P < 0.05) compared with those before treatment. More than 50% (17/32) of the patients reported that they were “very much improved” or “much improved” 30 minutes after the initial treatment, increasing to 93.8% (30/32) at 2 days post-treatment. One patient experienced mild allergic reaction after treatment. Limitation: Although this study had the largest sample size among current studies on treating PDPH with theophylline drugs, the sample size was still relatively small and the method employed was not compared with a placebo or other current clinical treatments for PDPH. Conclusion: An IV injection of aminophylline may be an effective and safe early-stage treatment for PDPH. Key words: Post-dural puncture headache, aminophylline, multicenter clinical study