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Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications (RAMPART)

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ClinicalTrials.gov Identifier: NCT00809146
Recruitment Status : Completed
First Posted : December 17, 2008
Results First Posted : April 13, 2012
Last Update Posted : June 17, 2016
Sponsor:
Collaborators:
Medical University of South Carolina
University of California, San Francisco
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Robert Silbergleit, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Status Epilepticus
Interventions Drug: Intramuscular route of active treatment
Drug: Intravenous route of active treatment
Enrollment 1023
Recruitment Details Subjects treated for status epilepticus in the prehospital setting by paramedics were enrolled at the scene between June 2009 and January 2011. A total of 1023 subject enrollments represented 893 unique subjects with a reenrollment rate of 13%. RAMPART involved 4314 paramedics, 33 EMS agencies, and 79 receiving hospitals across the United States.
Pre-assignment Details Number of patients enrolled includes any repeat enrollments for those who presented to emergency medical services (EMS) with status epilepticus more than once. The number assigned to treatment in the intention-to-treat analysis includes every patient who was enrolled in the study but only the initial enrollment for those enrolled more than once.
Arm/Group Title Intramuscular (IM) Anticonvulsant Intravenous (IV) Anticonvulsant
Hide Arm/Group Description This group gets active treatment with an anticonvulsant by the intramuscular route of administration. IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush. This group gets active treatment with an anticonvulsant by the intravenous route of administration. IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.
Period Title: Overall Study
Started 448 445
Completed 448 445
Not Completed 0 0
Arm/Group Title Intramuscular (IM) Anticonvulsant Intravenous (IV) Anticonvulsant Total
Hide Arm/Group Description This group gets active treatment with an anticonvulsant by the intramuscular route of administration. IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush. This group gets active treatment with an anticonvulsant by the intravenous route of administration. IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline. Total of all reporting groups
Overall Number of Baseline Participants 448 445 893
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 448 participants 445 participants 893 participants
43  (22) 44  (22) 43  (22)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 448 participants 445 participants 893 participants
0-5 years 32 29 61
6-10 years 15 20 35
11-20 years 28 21 49
21-40 years 114 112 226
41-60 years 169 169 338
>61 years 90 94 184
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 448 participants 445 participants 893 participants
Female
198
  44.2%
207
  46.5%
405
  45.4%
Male
250
  55.8%
238
  53.5%
488
  54.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 448 participants 445 participants 893 participants
Hispanic or Latino
49
  10.9%
57
  12.8%
106
  11.9%
Not Hispanic or Latino
310
  69.2%
290
  65.2%
600
  67.2%
Unknown or Not Reported
89
  19.9%
98
  22.0%
187
  20.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 448 participants 445 participants 893 participants
American Indian or Alaska Native
3
   0.7%
5
   1.1%
8
   0.9%
Asian
8
   1.8%
14
   3.1%
22
   2.5%
Native Hawaiian or Other Pacific Islander
2
   0.4%
1
   0.2%
3
   0.3%
Black or African American
229
  51.1%
224
  50.3%
453
  50.7%
White
165
  36.8%
183
  41.1%
348
  39.0%
More than one race
9
   2.0%
5
   1.1%
14
   1.6%
Unknown or Not Reported
32
   7.1%
13
   2.9%
45
   5.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 448 participants 445 participants 893 participants
448 445 893
Dose tier   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 448 participants 445 participants 893 participants
children with an estimated weight of 13 to 40 kg 62 59 121
Children estimated >40kg and All Adults 386 386 772
[1]
Measure Description: All adults and those children with an estimated body weight of more than 40 kg received either 10 mg of intramuscular midazolam followed by intravenous placebo or intramuscular placebo followed by 4 mg of intravenous lorazepam. Children with an estimated weight of 13 to 40 kg received either 5 mg of intramuscular midazolam followed by intravenous placebo or intramuscular placebo followed by 2 mg of intravenous lorazepam.
History of epilepsy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 448 participants 445 participants 893 participants
Yes 293 295 588
No 111 103 214
Not documented 44 47 91
Final diagnosis   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 448 participants 445 participants 893 participants
Status epilepticus 404 399 803
Nonepileptic spell 31 32 63
Undetermined 13 14 27
[1]
Measure Description: Determined by medical record review at the time of hospital discharge
1.Primary Outcome
Title Number of Subjects With Termination of Seizures at ED Arrival With no Rescue Therapy Given
Hide Description The primary outcome was termination of seizures before arrival in the emergency department (ED) without the need for the paramedics to provide rescue therapy. Subjects did not reach the primary outcome if they were having seizures on arrival in the emergency department or if they received rescue medication before arrival. Termination of seizures on arrival was determined according to the clinical judgment of the attending emergency physician and was based on examination of the subjects, their clinical course, and results of any routine diagnostic testing.
Time Frame Duration of prehospital care, outcome is determined upon arrival at the ED on the day of enrollment (average 20 minutes).
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IM Midazolam IV Lorazepam
Hide Arm/Group Description:
Subjects in whom the study IM autoinjector contained active treatment with midazolam
Subjects in whom the study IV infusion contained active treatment with lorazepam
Overall Number of Participants Analyzed 448 445
Measure Type: Number
Unit of Measure: participants
329 282
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IM Midazolam, IV Lorazepam
Comments The null hypothesis of inferiority was tested with a one-sided z statistic. Sample size was estimated assuming independent proportions, 2 interim analyses, 70% control event rate; 90% power; a noninferiority margin of 10%; and a 1-sided test with type I error probability of 0.025. A sample size of 890 (445 per treatment group) was inflated by 15% (1024 subjects) to account for inadvertent repeated enrollment of the same subjects. Repeated enrollments of the same subject were not analyzed.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assay sensitivity established by extensive review of lorazepam efficacy data. Noninferiority margin of 10% established by both clinical and statistical reasoning.
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method one-sided z statistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.10
Confidence Interval (2-Sided) 95%
0.04 to 0.16
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Number of Subjects With Endotracheal Intubation Within 30 Min After ED Arrival
Hide Description Endotracheal intubation performed or attempted by EMS or within 30 minutes after ED arrival is abstracted from the ED record physician and nursing records. Endotracheal intubation includes placement of a definitive tracheal airway (oro-, naso-, cricothyroidotomy, or tracheostomy) for support of respirations or protection of airway. Non-definitive and/or non-tracheal airways (oral or nasal airways, laryngeal mask airways, or esophageal obturator airways) are not included if the patient is not subsequently intubated unless specifically deemed to have been used in lieu of tracheal intubation.
Time Frame anytime before 30 minutes after ED arrival
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IM Midazolam IV Lorazepam
Hide Arm/Group Description:
Subjects in whom the study IM autoinjector contained active treatment with midazolam
Subjects in whom the study IV infusion contained active treatment with lorazepam
Overall Number of Participants Analyzed 448 445
Measure Type: Number
Unit of Measure: participants
63 64
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IM Midazolam, IV Lorazepam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.70 to 1.34
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Subjects Hospitalized
Hide Description Hospital and ICU admission from the ED, and length of stay, is abstracted from the hospital admission record. ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient.
Time Frame at ED disposition on day of enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IM Midazolam IV Lorazepam
Hide Arm/Group Description:
Subjects in whom the study IM autoinjector contained active treatment with midazolam
Subjects in whom the study IV infusion contained active treatment with lorazepam
Overall Number of Participants Analyzed 448 445
Measure Type: Number
Unit of Measure: participants
258 292
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IM Midazolam, IV Lorazepam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.88
Confidence Interval (2-Sided) 95%
0.79 to 0.98
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Number of Subjects Admitted to an Intensive Care Unit (ICU)
Hide Description Hospital and ICU admission from the ED, and length of stay, is abstracted from the hospital admission record. ICU admission is recorded as occurring only if the ICU is the initial inpatient unit for the patient.
Time Frame at time of disposition on day of enrollment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IM Midazolam IV Lorazepam
Hide Arm/Group Description:
Subjects in whom the study IM autoinjector contained active treatment with midazolam
Subjects in whom the study IV infusion contained active treatment with lorazepam
Overall Number of Participants Analyzed 448 445
Measure Type: Number
Unit of Measure: participants
128 161
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IM Midazolam, IV Lorazepam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.79
Confidence Interval (2-Sided) 95%
0.65 to 0.95
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Number of Subjects With Recurrent Seizure Within 12 Hours After ED Arrival
Hide Description Acute seizure recurrence is defined as any further convulsive or electrographic seizures occurring in the first 12 hours of hospitalization, if they require additional antiepileptic medications, in subjects that had been determined not to be having seizures on ED arrival.
Time Frame within 12 hours after ED arrival
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IM Midazolam IV Lorazepam
Hide Arm/Group Description:
Subjects in whom the study IM autoinjector contained active treatment with midazolam
Subjects in whom the study IV infusion contained active treatment with lorazepam
Overall Number of Participants Analyzed 448 445
Measure Type: Number
Unit of Measure: participants
51 47
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IM Midazolam, IV Lorazepam
Comments All participants were included in this analysis of rate of recurrence because this is the most clinically relevant denominator, although, by definition, only participants who stopped could have recurrent seizures.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.08
Confidence Interval (2-Sided) 95%
0.74 to 1.56
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Number of Subjects With Hypotension
Hide Description Acute hypotension is defined as a systolic blood pressure of < 90 mmHg sustained for greater than 5 minutes and for which the patient was treated with a continuous IV infusion of a vasopressor.
Time Frame participants were followed for the duration of hospital stay, an average of 6 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IM Midazolam IV Lorazepam
Hide Arm/Group Description:
Subjects in whom the study IM autoinjector contained active treatment with midazolam
Subjects in whom the study IV infusion contained active treatment with lorazepam
Overall Number of Participants Analyzed 448 445
Measure Type: Number
Unit of Measure: participants
12 13
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IM Midazolam, IV Lorazepam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.92
Confidence Interval (2-Sided) 95%
0.42 to 1.98
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Subjects With IM Injection-site Complications
Hide Description IM injection site complications are defined as any symptoms or signs of injury or reaction at the site of the study IM injection requiring treatment. This includes extensive hematoma requiring treatment (decompression, pressure dressings, or discontinuation of anticoagulant or antithrombotic medications). Treatment does not include imaging without other interventions. This definition also includes wound infection requiring antibiotic therapy, retained foreign bodies requiring exploration and removal, or other similar wound problems.
Time Frame participants were followed for the duration of hospital stay, an average of 6 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IM Midazolam IV Lorazepam
Hide Arm/Group Description:
Subjects in whom the study IM autoinjector contained active treatment with midazolam
Subjects in whom the study IV infusion contained active treatment with lorazepam
Overall Number of Participants Analyzed 448 445
Measure Type: Number
Unit of Measure: participants
4 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IM Midazolam, IV Lorazepam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.99
Confidence Interval (2-Sided) 95%
0.30 to 10.70
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Subjects With IV Injection-site Complications
Hide Description IV insertion site complications are defined as any symptoms or signs of injury or reaction at the site of the study IV placed by paramedics and used for study medication. This includes thrombosis, phlebitis, or skin infection requiring specific treatment including compresses, antibiotics, or wound care.
Time Frame participants were followed for the duration of hospital stay, an average of 6 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IM Midazolam IV Lorazepam
Hide Arm/Group Description:
Subjects in whom the study IM autoinjector contained active treatment with midazolam
Subjects in whom the study IV infusion contained active treatment with lorazepam
Overall Number of Participants Analyzed 448 445
Measure Type: Number
Unit of Measure: participants
0 3
9.Secondary Outcome
Title Length of Intensive Care Unit (ICU) Stay in Days
Hide Description Continuous days of initial ICU stay from time of admission
Time Frame participants were followed for the duration of hospital stay, an average of 6 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants with ICU length of stay data
Arm/Group Title IM Midazolam IV Lorazepam
Hide Arm/Group Description:
Subjects in whom the study IM autoinjector contained active treatment with midazolam
Subjects in whom the study IV infusion contained active treatment with lorazepam
Overall Number of Participants Analyzed 123 155
Mean (Standard Deviation)
Unit of Measure: days
5.7  (9.5) 4.1  (4.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IM Midazolam, IV Lorazepam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Length of Hospital Stay in Days
Hide Description Continuous acute care inpatient hospital days from day of admission until discharge
Time Frame participants were followed for the duration of hospital stay, an average of 6 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects with hospital length of stay data
Arm/Group Title IM Midazolam IV Lorazepam
Hide Arm/Group Description:
Subjects in whom the study IM autoinjector contained active treatment with midazolam
Subjects in whom the study IV infusion contained active treatment with lorazepam
Overall Number of Participants Analyzed 251 285
Mean (Standard Deviation)
Unit of Measure: days
6.7  (10.0) 5.5  (6.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IM Midazolam, IV Lorazepam
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.11
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame Serious adverse events were collected through subject end of study (emergency department or hospital discharge).
Adverse Event Reporting Description Number of participants at risk includes every enrollment (including repeat enrollments in some subjects). This reflects the number of interventions given.
 
Arm/Group Title IM Midazolam IV Lorazepam
Hide Arm/Group Description Subjects in whom the study IM autoinjector contained active treatment with midazolam Subjects in whom the study IV infusion contained active treatment with lorazepam
All-Cause Mortality
IM Midazolam IV Lorazepam
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IM Midazolam IV Lorazepam
Affected / at Risk (%) Affected / at Risk (%)
Total   137/514 (26.65%)   156/509 (30.65%) 
Blood and lymphatic system disorders     
Anemia *  1/514 (0.19%)  1/509 (0.20%) 
Transfusion reaction *  1/514 (0.19%)  0/509 (0.00%) 
Thrombocytopenia *  0/514 (0.00%)  1/509 (0.20%) 
Cardiac disorders     
Myocardial infarction *  5/514 (0.97%)  7/509 (1.38%) 
Hypotension *  5/514 (0.97%)  7/509 (1.38%) 
Atrial fibrillation *  0/514 (0.00%)  3/509 (0.59%) 
Bradycardia *  2/514 (0.39%)  0/509 (0.00%) 
Cardiac arrest *  2/514 (0.39%)  0/509 (0.00%) 
Ventricular tachycardia *  1/514 (0.19%)  0/509 (0.00%) 
Cardiogenic shock *  0/514 (0.00%)  1/509 (0.20%) 
Hypertension *  0/514 (0.00%)  1/509 (0.20%) 
Endocrine disorders     
Hypoglycemia *  2/514 (0.39%)  1/509 (0.20%) 
Hyperglycemic hyperosmolar nonketotic syndrome *  1/514 (0.19%)  0/509 (0.00%) 
Gastrointestinal disorders     
Pancreatitis acute *  1/514 (0.19%)  0/509 (0.00%) 
Vomiting/Nausea *  0/514 (0.00%)  1/509 (0.20%) 
General disorders     
Alcohol/Drug withdrawal syndrome *  5/514 (0.97%)  5/509 (0.98%) 
Hypothermia *  0/514 (0.00%)  2/509 (0.39%) 
Pyrexia *  0/514 (0.00%)  2/509 (0.39%) 
Chest pain *  1/514 (0.19%)  0/509 (0.00%) 
Hematoma *  1/514 (0.19%)  0/509 (0.00%) 
Infections and infestations     
Sepsis/SIRS/organ failure *  8/514 (1.56%)  8/509 (1.57%) 
Pneumonia/ Aspiration pneumonia *  2/514 (0.39%)  11/509 (2.16%) 
Cellulitis *  0/514 (0.00%)  1/509 (0.20%) 
Musculoskeletal and connective tissue disorders     
Rhabdomyolysis *  5/514 (0.97%)  5/509 (0.98%) 
Fracture *  0/514 (0.00%)  1/509 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Brain mass *  1/514 (0.19%)  1/509 (0.20%) 
Nervous system disorders     
Depressed level of consciousness *  49/514 (9.53%)  45/509 (8.84%) 
Convulsion *  33/514 (6.42%)  39/509 (7.66%) 
Mental status changes *  9/514 (1.75%)  10/509 (1.96%) 
Cerebral hemorrhage *  4/514 (0.78%)  0/509 (0.00%) 
Ischemic stroke *  2/514 (0.39%)  2/509 (0.39%) 
Encephalopathy *  1/514 (0.19%)  1/509 (0.20%) 
Delirium *  1/514 (0.19%)  0/509 (0.00%) 
Subarachnoid hemorrhage *  1/514 (0.19%)  0/509 (0.00%) 
Psychiatric disorders     
Suicidal ideation *  1/514 (0.19%)  0/509 (0.00%) 
Pseudoseizures *  1/514 (0.19%)  0/509 (0.00%) 
Psychosis *  0/514 (0.00%)  1/509 (0.20%) 
Renal and urinary disorders     
Renal failure, acute *  4/514 (0.78%)  0/509 (0.00%) 
Hematuria *  1/514 (0.19%)  0/509 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory depression *  33/514 (6.42%)  51/509 (10.02%) 
Pulmonary edema *  0/514 (0.00%)  2/509 (0.39%) 
Apnea *  1/514 (0.19%)  1/509 (0.20%) 
Pneumothorax *  1/514 (0.19%)  0/509 (0.00%) 
Hypoxia *  0/514 (0.00%)  1/509 (0.20%) 
Post-extubation stridor/airway obstruction *  0/514 (0.00%)  1/509 (0.20%) 
Stridor *  0/514 (0.00%)  1/509 (0.20%) 
Skin and subcutaneous tissue disorders     
Toxic epidermal necrolysis *  0/514 (0.00%)  1/509 (0.20%) 
Vascular disorders     
Deep vein thrombosis *  2/514 (0.39%)  0/509 (0.00%) 
Pulmonary embolism *  1/514 (0.19%)  1/509 (0.20%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
IM Midazolam IV Lorazepam
Affected / at Risk (%) Affected / at Risk (%)
Total   103/514 (20.04%)   95/509 (18.66%) 
Gastrointestinal disorders     
Vomiting/Nausea *  15/514 (2.92%)  23/509 (4.52%) 
General disorders     
Pyrexia *  23/514 (4.47%)  14/509 (2.75%) 
Nervous system disorders     
Convulsion *  45/514 (8.75%)  38/509 (7.47%) 
Mental status changes *  20/514 (3.89%)  20/509 (3.93%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Robert Silbergleit MD, Principal Investigator
Organization: University of Michigan
Phone: 734-232-2142
Responsible Party: Robert Silbergleit, University of Michigan
ClinicalTrials.gov Identifier: NCT00809146     History of Changes
Other Study ID Numbers: R01NS053031
5U01NS056975-02 ( U.S. NIH Grant/Contract )
First Submitted: December 15, 2008
First Posted: December 17, 2008
Results First Submitted: March 18, 2012
Results First Posted: April 13, 2012
Last Update Posted: June 17, 2016