MgSO4 vs Metoclopramide for Headache in Pregnant Women
Maneno muhimu
Kikemikali
Maelezo
Metoclopramide and prochlorperazine (Compazine®), antiemetic dopamine receptor antagonists, are widely used for headache treatment in North American emergency departments. Metoclopramide, FDA pregnancy category B, is used in clinical practice for acute headache in pregnant women. Small studies have found magnesium sulfate to be effective in migraine, tension and cluster headaches, although there is no data regarding efficacy or tolerability in pregnant women.
Our study would be similar to a Turkish study published in 2004 which compared magnesium sulfate to metoclopramide for acute headache treatment in nonpregnant individuals; they found the drugs equally effective 30 minutes after administration. Serum magnesium levels in pregnant women are often lower than in nonpregnant women; magnesium deficiency has been explored as contributing to headache frequency and severity. Magnesium sulfate use has been well established during pregnancy for decades, administered intravenously to delay labor or to women with preeclampsia for 24 to 48 hours, initially with 4 to 6 gram bolus then 2 grams per hour. For headache treatment, magnesium sulfate dose would be far lower, 2 grams. We would like to determine the efficacy and tolerability of magnesium sulfate for headache relief in pregnant women, as well as evaluate efficacy of metoclopramide in pregnant women. We do not find published randomized trials evaluating headache treatment in pregnant women.
Tarehe
| Imethibitishwa Mwisho: | 11/30/2012 |
| Iliyowasilishwa Kwanza: | 02/28/2008 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 03/09/2008 |
| Iliyotumwa Kwanza: | 03/10/2008 |
| Sasisho la Mwisho Liliwasilishwa: | 12/20/2012 |
| Sasisho la Mwisho Lilichapishwa: | 12/24/2012 |
| Tarehe halisi ya kuanza kwa masomo: | 07/31/2008 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 02/28/2010 |
| Tarehe ya Kukamilisha Utafiti: | 02/28/2010 |
Hali au ugonjwa
Uingiliaji / matibabu
Drug: Arm 1
Drug: Arm 2
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Active Comparator: Arm 1 magnesium sulfate 2 grams intravenously w/ acetaminophen 1 gram orally | Drug: Arm 1 magnesium sulfate 2 grams intravenously; both groups will receive acetaminophen (Tylenol®) 1 gram orally |
| Active Comparator: Arm 2 metoclopramide 10 mg intravenously w/ 1 gram acetominophen orally | Drug: Arm 2 metoclopramide 10 mg intravenously; both groups will receive acetaminophen (Tylenol®) 1 gram orally |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | Female |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - Pregnant, 18-75 - Headache rated 4 or greater on a 0-10 pain scale Exclusion Criteria: - New objective neurologic abnormality at the time of exam - Temperature >100.4 - Allergy or intolerance to study medications - Suspected of confirmed preeclampsia/eclampsia - Complete heart block - Hypotension, SBP<85 - Myasthenia gravis - End stage renal failure |
Matokeo
Hatua za Matokeo ya Msingi
1. The study will compare effectiveness of intravenous magnesium sulfate to that of intravenous metoclopramide (Reglan®) for acute headache in pregnant women. [1 year]
