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| ID | Type | Description | Link |
|---|---|---|---|
| UL1TR001073 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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This is a randomized study of intravenous metoclopramide + intravenous dexamethasone versus intravenous metoclopramide for patients with acute post-traumatic headache.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexamethasone | Experimental | Dexamethasone 10mg IV + metoclopramide 10mg IV |
|
| Placebo | Placebo Comparator | Placebo IV + metoclopramide 10mg IV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone 10mg IV |
| |
| Metoclopramide 10mg |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge | Headache intensity will be rated based on the International Headache Society (IHS) 4-point scale. Using this scale participants will verbalize whether their headache intensity is "Severe," "Moderate," "Mild," or "None." The percentage of patients reporting a headache intensity level of either "Moderate" or "Severe" will be grouped and summarized by study arm. The number/percentage of patients reporting a headache intensity level of "Mild" or "None" will also be grouped and summarized by study arm. Between-group difference along with 95% confidence intervals will be reported. Patients who use an analgesic or abortive headache medication during the 48-hour period will be considered an outcome failure. | From ED discharge to 48-hours following discharge from the ED, up to 2 days total |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Headache Relief | Sustained headache pain relief will be defined as the number of patients achieving a headache intensity of "mild" or "none" after administration of study medication and who maintain that level for 48 hours without the use of rescue medication. The percentage of patients reporting a headache intensity level of either "mild" or "none" will be considered to have achieved and maintained sustained headache relief and will be summarized by study arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days With Headache During the Week After ED Discharge | The mean number of days with headache during the 1-week period following discharge will be summarized by study arm using basic descriptive statistics | Up to 1 week after ED discharge, up to 7 days total |
Inclusion Criteria:
Meet International Classification of Headache Disorders (3rd edition) criteria for acute post-traumatic headache as follows:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Friedman, MD | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore | The Bronx | New York | 10467 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20709244 | Background | Blyth BJ, Bazarian JJ. Traumatic alterations in consciousness: traumatic brain injury. Emerg Med Clin North Am. 2010 Aug;28(3):571-94. doi: 10.1016/j.emc.2010.03.003. | |
| 38575256 | Background | Evans RW. The Postconcussion Syndrome and Posttraumatic Headaches in Civilians, Soldiers, and Athletes. Neurol Clin. 2024 May;42(2):341-373. doi: 10.1016/j.ncl.2023.12.001. Epub 2024 Jan 16. |
Not provided
Not provided
The de-identified dataset will be made available to clinical researchers upon approval of the analytic plan. Requests should be made to the corresponding author.
Upon approval of the analytic plan.
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2,220 patients were screened for participation and 162 were enrolled as research participants. Despite repeated attempts, 8 study participants within each arm were unable to be contacted after discharge from the ED.
The study was conducted in two emergency departments in the Bronx, New York. Enrollment commenced in June 2021 and completed in November 2024.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dexamethasone | Dexamethasone 10mg IV + metoclopramide 10mg IV Dexamethasone: Dexamethasone 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV |
| FG001 | Placebo | Placebo IV + metoclopramide 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dexamethasone | Dexamethasone 10mg IV + metoclopramide 10mg IV Dexamethasone: Dexamethasone 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV |
| BG001 | Placebo | Placebo IV + metoclopramide 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge | Headache intensity will be rated based on the International Headache Society (IHS) 4-point scale. Using this scale participants will verbalize whether their headache intensity is "Severe," "Moderate," "Mild," or "None." The percentage of patients reporting a headache intensity level of either "Moderate" or "Severe" will be grouped and summarized by study arm. The number/percentage of patients reporting a headache intensity level of "Mild" or "None" will also be grouped and summarized by study arm. Between-group difference along with 95% confidence intervals will be reported. Patients who use an analgesic or abortive headache medication during the 48-hour period will be considered an outcome failure. | Data were unable to be collected from 8 patients in the Dexamethasone arm and 8 patients in the Placebo arm. Outcome failures in the description were not excluded from analysis. This was registered inadvertently as this was not part of the study plan and is inconsistent with the IRB approved protocol. | Posted | Count of Participants | Participants | From ED discharge to 48-hours following discharge from the ED, up to 2 days total |
Hourly in the ED and during the 48-hour follow-up period following the treatment intervention, up to 2 days total.
Adverse events were elicited using the simple dichotomous question, "Did you experience any new symptoms after receiving the study medications?", followed by an open-ended question "Please tell us about these symptoms."
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dexamethasone | Dexamethasone 10mg IV + metoclopramide 10mg IV Dexamethasone: Dexamethasone 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Somnolence | Nervous system disorders | Non-systematic Assessment | Verbatim term: Drowsiness |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Friedman | Montefiore Medical Center | 718-920-6626 | befriedm@montefiore.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 29, 2021 | Feb 1, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 10, 2024 | Feb 1, 2026 | ICF_001.pdf |
Not provided
Not provided
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| ID | Term |
|---|---|
| D051298 | Post-Traumatic Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D008787 | Metoclopramide |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
Not provided
Not provided
Randomization occurred in a 1:1 ratio in blocks of four.
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| Drug |
Metoclopramide 10mg IV |
|
| 48 hours after administration of study medication |
| Post Concussive Symptoms | Post concussive symptoms at 48 hours will be assessed using the Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). Using the validated SCAT PCSS patients rate the severity of 22 concussive symptoms on a 7-point Likert scale ranging from 0 ("none") to 6 ("severe") yielding an overall possible scoring range of 0-132. Higher SCAT PCSS scores are indicative greater severity of post-concussive symptoms. Results will be summarized by study arm using basic descriptive statistics. | 48 hours after ED discharge, up to 2 days total |
| Post Concussive Symptoms | Post concussive symptoms at 7 days will be assessed using the Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). Using the validated SCAT PCSS patients rate the severity of 22 concussive symptoms on a 7-point Likert scale ranging from 0 ("none") to 6 ("severe") yielding an overall possible scoring range of 0-132. Higher SCAT PCSS scores are indicative of greater severity of post-concussive symptoms. Results will be summarized by study arm using basic descriptive statistics. | 7 days after ED discharge, up to 7 days total |
| Use of Rescue Medication in the ED | Use of rescue medication will be defined as the number of patients administered any analgesic medication or headache abortive medication while in the ED. The number of patients who used rescue medication while in the ED will be summarized by study arm. | Duration of ED admission, less than 1 day |
| 40252247 | Background | Shah R, Das S, Gentile Kruse CF, de Prado BM, Raj N, Evans M, Panigrahi P, Hershey AD, Master CL, Szperka CL, Patterson Gentile C. Patterns of Use and Benefit of Triptans in the Treatment of Acute Headache Worsening in Youth With Post-Traumatic Headache. Pediatr Neurol. 2025 Jun;167:96-102. doi: 10.1016/j.pediatrneurol.2025.03.013. Epub 2025 Mar 27. |
| 34862612 | Background | Patterson Gentile C, Shah R, Irwin SL, Greene K, Szperka CL. Acute and chronic management of posttraumatic headache in children: A systematic review. Headache. 2021 Nov;61(10):1475-1492. doi: 10.1111/head.14236. Epub 2021 Dec 4. |
| 31638888 | Background | Larsen EL, Ashina H, Iljazi A, Al-Khazali HM, Seem K, Ashina M, Ashina S, Schytz HW. Acute and preventive pharmacological treatment of post-traumatic headache: a systematic review. J Headache Pain. 2019 Oct 21;20(1):98. doi: 10.1186/s10194-019-1051-7. |
| 33762421 | Background | Friedman BW, Irizarry E, Cain D, Caradonna A, Minen MT, Solorzano C, Zias E, Zybert D, McGregor M, Bijur PE, Gallagher EJ. Randomized Study of Metoclopramide Plus Diphenhydramine for Acute Posttraumatic Headache. Neurology. 2021 May 4;96(18):e2323-e2331. doi: 10.1212/WNL.0000000000011822. Epub 2021 Mar 24. |
| 27300483 | Background | Orr SL, Friedman BW, Christie S, Minen MT, Bamford C, Kelley NE, Tepper D. Management of Adults With Acute Migraine in the Emergency Department: The American Headache Society Evidence Assessment of Parenteral Pharmacotherapies. Headache. 2016 Jun;56(6):911-40. doi: 10.1111/head.12835. |
| 23034499 | Background | Bramley H, Melinosky C, Silvis M, Ross S. Pediatric posttraumatic headache: two cases using steroids as abortive therapy. Pediatr Emerg Care. 2012 Oct;28(10):1081-4. doi: 10.1097/PEC.0b013e31826ceeeb. |
| 31550910 | Background | Navratilova E, Rau J, Oyarzo J, Tien J, Mackenzie K, Stratton J, Remeniuk B, Schwedt T, Anderson T, Dodick D, Porreca F. CGRP-dependent and independent mechanisms of acute and persistent post-traumatic headache following mild traumatic brain injury in mice. Cephalalgia. 2019 Dec;39(14):1762-1775. doi: 10.1177/0333102419877662. Epub 2019 Sep 24. |
| 34125320 | Background | Kamins J. Models for Treating Post-traumatic Headache. Curr Pain Headache Rep. 2021 Jun 14;25(8):52. doi: 10.1007/s11916-021-00970-3. |
| 38559532 | Background | Zeng Z, Wei L, Zhang H, Chen W, Wang S. The Effect of Dexamethasone on Neuroinflammation and Cerebral Edema in Rats With Traumatic Brain Injury Combined With Seawater Drowning. Cureus. 2024 Mar 1;16(3):e55309. doi: 10.7759/cureus.55309. eCollection 2024 Mar. |
| 34928511 | Background | Barlow KM. Post-traumatic headache: An unmet medical need. Headache. 2021 Nov;61(10):1465-1466. doi: 10.1111/head.14241. No abstract available. |
| 37515405 | Background | May A, Evers S, Goadsby PJ, Leone M, Manzoni GC, Pascual J, Carvalho V, Romoli M, Aleksovska K, Pozo-Rosich P, Jensen RH; European Academy of Neurology Task Force. European Academy of Neurology guidelines on the treatment of cluster headache. Eur J Neurol. 2023 Oct;30(10):2955-2979. doi: 10.1111/ene.15956. Epub 2023 Jul 28. |
| 29368949 | Background | Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available. |
| 30449536 | Background | Latev A, Friedman BW, Irizarry E, Solorzano C, Restivo A, Chertoff A, Zias E, Gallagher EJ. A Randomized Trial of a Long-Acting Depot Corticosteroid Versus Dexamethasone to Prevent Headache Recurrence Among Patients With Acute Migraine Who Are Discharged From an Emergency Department. Ann Emerg Med. 2019 Feb;73(2):141-149. doi: 10.1016/j.annemergmed.2018.09.028. Epub 2018 Nov 16. |
| 37604662 | Background | Friedman BW, Solorzano C, Kessler BD, Martorello K, Lutz CL, Feliciano C, Adler N, Moss H, Cain D, Irizarry E. Randomized Trial Comparing Low- vs High-Dose IV Dexamethasone for Patients With Moderate to Severe Migraine. Neurology. 2023 Oct 3;101(14):e1448-e1454. doi: 10.1212/WNL.0000000000207648. Epub 2023 Aug 21. |
| 38518177 | Background | Ashina H, Diener HC, Tassorelli C, Scher AI, Lipton RB, Pozo-Rosich P, Sinclair AJ, Chong CD, Finkel AG, Ashina M, Schwedt TJ, Dodick DW, Terwindt GM. Guidelines of the International Headache Society for controlled trials of pharmacological preventive treatment for persistent post-traumatic headache attributed to mild traumatic brain injury. Cephalalgia. 2024 Mar;44(3):3331024241234068. doi: 10.1177/03331024241234068. |
| 30806518 | Background | Diener HC, Tassorelli C, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ, Mandrekar J; International Headache Society Clinical Trials Standing Committee. Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition. Cephalalgia. 2019 May;39(6):687-710. doi: 10.1177/0333102419828967. Epub 2019 Feb 26. |
| 27281276 | Background | Chin EY, Nelson LD, Barr WB, McCrory P, McCrea MA. Reliability and Validity of the Sport Concussion Assessment Tool-3 (SCAT3) in High School and Collegiate Athletes. Am J Sports Med. 2016 Sep;44(9):2276-85. doi: 10.1177/0363546516648141. Epub 2016 Jun 8. |
| 29074068 | Background | Friedman BW, Babbush K, Irizarry E, White D, John Gallagher E. An exploratory study of IV metoclopramide+diphenhydramine for acute post-traumatic headache. Am J Emerg Med. 2018 Feb;36(2):285-289. doi: 10.1016/j.ajem.2017.10.034. Epub 2017 Oct 13. |
| 41506783 | Derived | Joudi K, Nsenga A, Williams AR, Lee SI, Johnson S, Irizarry E, Friedman BW. IV dexamethasone as adjuvant therapy to metoclopramide for acute posttraumatic headache in the ED: A randomized controlled trial. Headache. 2026 May;66(5):1081-1087. doi: 10.1111/head.70027. Epub 2026 Jan 8. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Headache Duration | Upon admission to the ED, patients were queried as to the median duration of their reported headache. Results are summarized by duration of headache, in hours, by study arm. | Median | Inter-Quartile Range | hours |
|
| Baseline Headache Intensity | Participants were asked to quantify their headache using the following descriptors: "Severe", "Moderate", "Mild" or "None". No other cues/descriptions were provided. In order to be eligible for the trial participants must have rated their headache as either "Moderate" or "Severe" in intensity at the time of initial evaluation. The number of participants who reported "Moderate" or "Severe" headache intensity is summarized by study arm. | Count of Participants | Participants |
|
| Mechanism of Injury | The mechanism of injury leading to the patient's post-traumatic headache visit to the ED is summarized by study arm using categorical variables. | Count of Participants | Participants |
|
| Loss of Consciousness | Loss of consciousness (LoC) was assessed by querying patients at baseline as to whether they experienced any LoC ("Yes"), did not experience LoC ("No") or were unsure as to whether they had LoC ("Not sure"). Results are summarized by study arm. | Count of Participants | Participants |
|
| Post Concussive Symptoms | Post concussive symptoms at baseline were assessed using the Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). Using the validated SCAT PCSS patients rate the severity of 22 concussive symptoms on a 7-point Likert scale ranging from 0 ("none") to 6 ("severe") yielding an overall possible scoring range of 0-132. Higher SCAT PCSS scores were indicative greater severity of post-concussive symptoms. | Post-concussive symptom data was not available from 1 of the patients in the Dexamethasone arm. | Median | Inter-Quartile Range | score on a scale |
|
| ID | Title | Description |
|---|
| OG000 | Dexamethasone | Dexamethasone 10mg IV + metoclopramide 10mg IV Dexamethasone: Dexamethasone 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV |
| OG001 | Placebo | Placebo IV + metoclopramide 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV |
|
|
|
| Secondary | Sustained Headache Relief | Sustained headache pain relief will be defined as the number of patients achieving a headache intensity of "mild" or "none" after administration of study medication and who maintain that level for 48 hours without the use of rescue medication. The percentage of patients reporting a headache intensity level of either "mild" or "none" will be considered to have achieved and maintained sustained headache relief and will be summarized by study arm. | Data were unable to be collected from 4 patients in the Dexamethasone arm and 2 patients in the Placebo arm. | Posted | Count of Participants | Participants | 48 hours after administration of study medication |
|
|
|
|
| Secondary | Post Concussive Symptoms | Post concussive symptoms at 48 hours will be assessed using the Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). Using the validated SCAT PCSS patients rate the severity of 22 concussive symptoms on a 7-point Likert scale ranging from 0 ("none") to 6 ("severe") yielding an overall possible scoring range of 0-132. Higher SCAT PCSS scores are indicative greater severity of post-concussive symptoms. Results will be summarized by study arm using basic descriptive statistics. | Post-concussive symptom data was not collected at 48 hours post-ED discharge due to an error in the data collection form. Specifically, the form did not query patients for symptoms during this collection interval and, consequently, no PCSS scores are available to report at the 48 hours post-discharge timepoint. While the opportunity to collect data at this timepoint was missed, PCSS scores are available at 1 hour and 7 days post-ED discharge | Posted | 48 hours after ED discharge, up to 2 days total |
|
|
| Secondary | Post Concussive Symptoms | Post concussive symptoms at 7 days will be assessed using the Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). Using the validated SCAT PCSS patients rate the severity of 22 concussive symptoms on a 7-point Likert scale ranging from 0 ("none") to 6 ("severe") yielding an overall possible scoring range of 0-132. Higher SCAT PCSS scores are indicative of greater severity of post-concussive symptoms. Results will be summarized by study arm using basic descriptive statistics. | Post-concussive symptom data was unable to be collected from 2 patients in the Dexamethasone arm and from 1 patient in the Placebo arm. | Posted | Median | Inter-Quartile Range | score on a scale | 7 days after ED discharge, up to 7 days total |
|
|
|
|
| Secondary | Use of Rescue Medication in the ED | Use of rescue medication will be defined as the number of patients administered any analgesic medication or headache abortive medication while in the ED. The number of patients who used rescue medication while in the ED will be summarized by study arm. | Posted | Count of Participants | Participants | Duration of ED admission, less than 1 day |
|
|
|
|
| Other Pre-specified | Number of Days With Headache During the Week After ED Discharge | The mean number of days with headache during the 1-week period following discharge will be summarized by study arm using basic descriptive statistics | Data were unable to be collected from 1 patient in the Dexamethasone arm and 1 patient in the Placebo arm. | Posted | Mean | Standard Deviation | days | Up to 1 week after ED discharge, up to 7 days total |
|
|
|
| Post-Hoc | Headache Pain Intensity | Headache pain intensity was assessed one hour after administration of study medication in the ED. Participants were asked to quantify their headache using the following descriptors: "Severe", "Moderate", "Mild" or "None". No other cues/descriptions were provided. Results are summarized by study arm. | Data from 1 patient in the Dexamethasone arm was unavailable. | Posted | Count of Participants | Participants | 1 hour after administration of study medication |
|
|
|
| Post-Hoc | Use of Rescue Medication Post-discharge | Use of rescue medication post-discharge will be defined as the number of patients administered any analgesic medication or headache abortive medication during the 48-hour period following discharge. The number of patients who used rescue medication during this period are summarized by study arm. | Data were unable to be collected from 1 patient in the Dexamethasone and 1 patient in the Placebo arm. | Posted | Count of Participants | Participants | Up to 48 hours following discharge from the ED, up to 2 days total |
|
|
|
| Post-Hoc | Assessment of Blinding | Patient assessment of blinding was determined by surveying the patients as to whether they believed they received actual study drug medication, placebo, or were not sure whether they received actual study drug medication or placebo. Categorical variables were summarized by study arm. | Posted | Count of Participants | Participants | 48 hours following medication administration |
|
|
|
| Post-Hoc | Post Concussive Symptoms | Post concussive symptoms at 1 hour will be assessed using the Sport Concussion Assessment Tool (SCAT) Post Concussion Symptom Scale (PCSS). Using the validated SCAT PCSS patients rate the severity of 22 concussive symptoms on a 7-point Likert scale ranging from 0 ("none") to 6 ("severe") yielding an overall possible scoring range of 0-132. Higher SCAT PCSS scores are indicative of greater severity of post-concussive symptoms. Results will be summarized by study arm using basic descriptive statistics. | Post-concussive symptom data were unable to be collected from 4 patients in the Dexamethasone arm and 3 patients in the Placebo arm | Posted | Median | Inter-Quartile Range | score on a scale | 1 hour |
|
|
|
|
| 0 |
| 81 |
| 0 |
| 81 |
| 12 |
| 81 |
| EG001 | Placebo | Placebo IV + metoclopramide 10mg IV Metoclopramide 10mg: Metoclopramide 10mg IV | 0 | 81 | 0 | 81 | 9 | 81 |
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | Non-systematic Assessment |
|
| Blurred Vision | Eye disorders | Non-systematic Assessment | Verbatim Term: Blurry Vision |
|
| Chills | General disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Irritability | Psychiatric disorders | Non-systematic Assessment | Verbatim Term: Irritable |
|
| Flushing | Vascular disorders | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D009422 | Nervous System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D062366 | para-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D002723 | Chlorobenzoates |
| D062425 | Hydroxybenzoate Ethers |
| D062385 | Hydroxybenzoates |
| D006880 | Hydroxy Acids |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010647 | Phenyl Ethers |
| D010636 | Phenols |
| Moderate |
|
| Severe |
|
| Not sure |
|