Earmuff and eye mask in the treatment of acute primary headache in emergency department: a randomized controlled open label study
Abstract
Background: Patients presenting to the ED with headache are placed in a quiet, darkened room to minimize external stimuli; however, creating and maintaining such an environment can be challenging in the context of a busy ED setting. This study evaluated whether adding noise-reduction earmuffs and sleep eye masks to standard metoclopramide therapy improves pain relief in adult patients presenting with acute primary headache in the emergency department.
Methods: This single-center, open-label, randomized, controlled, parallel-group trial was conducted in the urban emergency department of a tertiary care hospital. Adult patients diagnosed with primary headache were randomized (1:1:1:1) to receive: Standard treatment alone (10 mg metoclopramide in 150 mL normal saline over 10 min). Standard treatment plus earmuffs (3 M Peltor Optime III, SNR 35 dB). Standard treatment plus a disposable sleep eye mask (> 99.9% light blockage). Standard treatment plus both earmuffs and an eye mask. Pain intensity was recorded on a 100 mm visual analogue scale (VAS) at baseline (VAS0), 30 min (VAS30), and 60 min (VAS60). Primary outcomes were the differences ΔVAS30 and ΔVAS60 versus baseline. Before the study, we calculated that 34 patients in each group would be sufficient to detect a 13 mm difference between the ΔVAS scores between the groups that would be clinically significant.
Results: Of the 194 screened patients, 140 were randomized (n = 35 per group) and analyzed by intention to treat. At…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 194 participants or records.
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