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I-FiBH trial: intravenous fluids in benign headaches-a randomised, single-blinded clinical trial.
Emerg Med J. 2020 Aug; 37(8):469-473.EM

Abstract

BACKGROUND

Many emergency physicians use an intravenous fluid bolus as part of a 'cocktail' of therapies for patients with headache, but it is unclear if this is beneficial. The objective of this study was to determine if an intravenous fluid bolus helps reduce pain or improve other outcomes in patients who present to the ED with a benign headache.

METHODS

This was a randomised, single-blinded, clinical trial performed on patients aged 10-65 years old with benign headaches who presented to a single ED in Las Vegas, Nevada, from May 2017 to February 2019. All patients received prochlorperazine and diphenhydramine, and they were randomised to also receive either 20 mL/kg up to 1000 mL of normal saline (the fluid bolus group) or 5 mL of normal saline (the control group). The primary outcome was the difference between groups in mean pain reduction 60 min after the initiation of treatment. Secondarily, we compared groups with regards to pain reduction at 30 min, nausea scores, the use of rescue medications and disposition.

RESULTS

We screened 67 patients for enrolment, and 58 consented. Of those, 35 were randomised to the fluid bolus group and 23 to the control group. The mean pain score dropped by 48.3 mm over 60 min in the fluid bolus group, compared with 48.7 mm in the control group. The between groups difference of 0.4 mm (95% CI -16.5 to 17.3) was not statistically significant (p=0.96). Additionally, no statistically significant difference was found between groups for any secondary outcome.

CONCLUSION

Though our study lacked statistical power to detect small but clinically significant differences, ED patients who received an intravenous fluid bolus for their headache had similar improvements in pain and other outcomes compared with those who did not.

TRIAL REGISTRATION NUMBER

NCT03185130.

Authors+Show Affiliations

Department of Emergency Medicine, Kendall Regional Medical Center, Miami, Florida, USA zitek10@gmail.com.Department of Emergency Medicine, Mike O'Callaghan Federal Medical Center, Nellis Afb, Nevada, USA.Department of Emergency Medicine, University of Nevada, Las Vegas School of Medicine, Las Vegas, Nevada, USA.Department of Emergency Medicine, University Medical Center of Southern Nevada, Las Vegas, Nevada, USA.Department of Emergency Medicine, University Medical Center of Southern Nevada, Las Vegas, Nevada, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32620543

Citation

Zitek, Tony, et al. "I-FiBH Trial: Intravenous Fluids in Benign Headaches-a Randomised, Single-blinded Clinical Trial." Emergency Medicine Journal : EMJ, vol. 37, no. 8, 2020, pp. 469-473.
Zitek T, Sigal T, Sun G, et al. I-FiBH trial: intravenous fluids in benign headaches-a randomised, single-blinded clinical trial. Emerg Med J. 2020;37(8):469-473.
Zitek, T., Sigal, T., Sun, G., Martin Manuel, C., & Tran, K. (2020). I-FiBH trial: intravenous fluids in benign headaches-a randomised, single-blinded clinical trial. Emergency Medicine Journal : EMJ, 37(8), 469-473. https://doi.org/10.1136/emermed-2019-209389
Zitek T, et al. I-FiBH Trial: Intravenous Fluids in Benign Headaches-a Randomised, Single-blinded Clinical Trial. Emerg Med J. 2020;37(8):469-473. PubMed PMID: 32620543.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - I-FiBH trial: intravenous fluids in benign headaches-a randomised, single-blinded clinical trial. AU - Zitek,Tony, AU - Sigal,Tiffany, AU - Sun,Gina, AU - Martin Manuel,Chris, AU - Tran,Khanhha, Y1 - 2020/07/03/ PY - 2019/12/20/received PY - 2020/05/21/revised PY - 2020/05/25/accepted PY - 2020/7/6/pubmed PY - 2020/7/6/medline PY - 2020/7/5/entrez KW - headache SP - 469 EP - 473 JF - Emergency medicine journal : EMJ JO - Emerg Med J VL - 37 IS - 8 N2 - BACKGROUND: Many emergency physicians use an intravenous fluid bolus as part of a 'cocktail' of therapies for patients with headache, but it is unclear if this is beneficial. The objective of this study was to determine if an intravenous fluid bolus helps reduce pain or improve other outcomes in patients who present to the ED with a benign headache. METHODS: This was a randomised, single-blinded, clinical trial performed on patients aged 10-65 years old with benign headaches who presented to a single ED in Las Vegas, Nevada, from May 2017 to February 2019. All patients received prochlorperazine and diphenhydramine, and they were randomised to also receive either 20 mL/kg up to 1000 mL of normal saline (the fluid bolus group) or 5 mL of normal saline (the control group). The primary outcome was the difference between groups in mean pain reduction 60 min after the initiation of treatment. Secondarily, we compared groups with regards to pain reduction at 30 min, nausea scores, the use of rescue medications and disposition. RESULTS: We screened 67 patients for enrolment, and 58 consented. Of those, 35 were randomised to the fluid bolus group and 23 to the control group. The mean pain score dropped by 48.3 mm over 60 min in the fluid bolus group, compared with 48.7 mm in the control group. The between groups difference of 0.4 mm (95% CI -16.5 to 17.3) was not statistically significant (p=0.96). Additionally, no statistically significant difference was found between groups for any secondary outcome. CONCLUSION: Though our study lacked statistical power to detect small but clinically significant differences, ED patients who received an intravenous fluid bolus for their headache had similar improvements in pain and other outcomes compared with those who did not. TRIAL REGISTRATION NUMBER: NCT03185130. SN - 1472-0213 UR - https://www.unboundmedicine.com/medline/citation/32620543/I-FiBH_trial:_intravenous_fluids_in_benign_headaches-a_randomised,_single-blinded_clinical_trial L2 - http://emj.bmj.com/cgi/pmidlookup?view=long&pmid=32620543 DB - PRIME DP - Unbound Medicine ER -
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