Am J Perinatol 2018; 35(13): 1281-1286
DOI: 10.1055/s-0038-1646952
Original Article
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Metoclopramide and Diphenhydramine: A Randomized Controlled Trial of a Treatment for Headache in Pregnancy when Acetaminophen Alone Is Ineffective (MAD Headache Study)

Katherine M. Scolari Childress
1   Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Women's Health, Saint Louis University School of Medicine, St. Louis, Missouri
,
Christina Dothager
1   Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Women's Health, Saint Louis University School of Medicine, St. Louis, Missouri
,
Jeffrey A. Gavard
1   Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Women's Health, Saint Louis University School of Medicine, St. Louis, Missouri
,
Sara Lebovitz
1   Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Women's Health, Saint Louis University School of Medicine, St. Louis, Missouri
,
Catherine Laska
1   Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Women's Health, Saint Louis University School of Medicine, St. Louis, Missouri
,
Dorothea J. Mostello
1   Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Women's Health, Saint Louis University School of Medicine, St. Louis, Missouri
› Author Affiliations
Funding None.
Further Information

Publication History

18 September 2017

21 March 2018

Publication Date:
03 May 2018 (online)

Abstract

Objective We investigated whether metoclopramide administered with diphenhydramine (MAD) relieves headache in pregnant women when acetaminophen alone is ineffective, using codeine for comparison.

Study Design Normotensive pregnant women in the second or third trimester were randomized to MAD intravenously (10 mg and 25 mg, respectively) or codeine orally (30 mg) for headache after 650 to 1,000 mg of acetaminophen failed to relieve their headaches. Headache severity (pain score 0–10) was noted at intervals over 24 hours. The primary outcome was reduction in pain score 6 hours after medication administration. A sample size calculation of 35 patients per group was based on estimated reduction in headache pain score by at least two points, with an α of 0.05 and a power of 80%.

Results No difference was seen in the primary outcome. MAD pain scores were lower at 30 minutes (3 ± 2.8 versus 5.8 ± 2.3, p < 0.001), 1 hour (2.2 ± 2.3 vs. 4.1 ± 3; p < 0.01), and 12 hours (1.3 ± 2.5 vs. 2.7 ± 3; p < 0.05), but not at 6 hours. Time to perceived headache relief was shorter for MAD than for codeine (20.2 ± 13.4 vs. 62.4 ± 62.2 minutes; p < 0.001). More patients in the MAD group reported full headache relief within 24 hours (76.5 vs. 37.5%; p < 0.01).

Conclusion MAD effectively relieves headaches in pregnant women when acetaminophen fails.

 
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