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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.
ClinicalTrials.gov identifier NCT02522013.
Classification of evidence This study provides Class I evidence that for people with PDPH, IV aminophylline reduces headache severity.
Glossary
- EBP=
- epidural blood patch;
- PDPH=
- postdural puncture headache;
- PGIC=
- Patient Global Impression of Change;
- VAS=
- visual analog scale
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Class of Evidence: NPub.org/coe
CME Course: NPub.org/cmelist
- Received August 28, 2017.
- Accepted in final form January 25, 2018.
- © 2018 American Academy of Neurology
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