Aminophylline for treatment of postdural puncture headache: A randomized clinical trial

Neurology. 2018 Apr 24;90(17):e1523-e1529. doi: 10.1212/WNL.0000000000005351. Epub 2018 Mar 23.

Abstract

Objective: To investigate the efficacy and safety of IV aminophylline for patients with postdural puncture headache (PDPH).

Methods: We randomly assigned patients to groups receiving either 250 mg IV aminophylline or a placebo within 3 hours of symptom onset once daily for 2 consecutive days. The primary endpoint was headache severity 8 hours after treatment. We assessed this using visual analog scale (VAS) scores taken from patients in a standing position. We also recorded posttreatment VAS score changes, Patient Global Impression of Change (PGIC) scores, and adverse events. We performed an intention-to-treat analysis.

Results: We enrolled 126 patients with PDPH at 5 centers in China (62 assigned to the aminophylline group and 64 to the placebo group). The median age was 37 years, and 96 (76.2%) patients were women. Compared to the placebo-treated patients, the aminophylline-treated patients had significantly lower mean VAS scores 8 hours after treatment (5.34 vs 2.98, p < 0.001) and were significantly more likely to report improvements on the PGIC (39.1% vs 72.6%, p < 0.01). This therapeutic effect was already evident at the 30-minute time point and persisted for 2 days. There was no significant difference in the incidence of adverse events (4.8% vs 1.6%, p = 0.589).

Conclusions: IV aminophylline is an effective and safe early-stage treatment for patients with PDPH.

Clinicaltrialsgov identifier: NCT02522013.

Classification of evidence: This study provides Class I evidence that for people with PDPH, IV aminophylline reduces headache severity.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Intravenous
  • Adolescent
  • Adult
  • Aged
  • Aminophylline / therapeutic use*
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Phosphodiesterase Inhibitors / therapeutic use*
  • Post-Dural Puncture Headache / drug therapy*
  • Statistics, Nonparametric
  • Treatment Outcome
  • Visual Analog Scale
  • Young Adult

Substances

  • Phosphodiesterase Inhibitors
  • Aminophylline

Associated data

  • ClinicalTrials.gov/NCT02522013