Trial Outcomes & Findings for Valproate Versus Ketorolac Versus Metoclopramide (NCT NCT01267864)

NCT ID: NCT01267864

Last Updated: 2018-06-04

Results Overview

Verbal Numerical Rating scale for pain. Absolute change from baseline. This is a 0-10 scale on which 0= no pain and 10= the worst pain imaginable.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 330 participants
• Primary outcome timeframe: 60 minutes after receipt of medication
• Results posted on: 2018-06-04

Participant Flow

Participant milestones

Measure	Metoclopramide Metoclopramide 10mg IVSS Metoclorpamide: 10mg IVSS	Ketorolac Ketorolac 30mg IV Ketorolac: 30g IVSS	Valproate 1gm IV Valproate: 1gm IVSS
Overall Study STARTED	110	110	110
Overall Study COMPLETED	110	110	110
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Valproate Versus Ketorolac Versus Metoclopramide

Baseline characteristics by cohort

Measure	Metoclopramide n=110 Participants Metoclopramide 10mg IVSS Metoclorpamide: 10mg IVSS	Ketorolac n=110 Participants Ketorolac 30mg IV Ketorolac: 30g IVSS	Valproate n=110 Participants 1gm IV Valproate: 1gm IVSS	Total n=330 Participants Total of all reporting groups
Age, Continuous	34 years n=5 Participants	34 years n=7 Participants	33 years n=5 Participants	33 years n=4 Participants
Sex: Female, Male Female	92 Participants n=5 Participants	93 Participants n=7 Participants	91 Participants n=5 Participants	276 Participants n=4 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	17 Participants n=7 Participants	19 Participants n=5 Participants	54 Participants n=4 Participants

PRIMARY outcome

Timeframe: 60 minutes after receipt of medication

Verbal Numerical Rating scale for pain. Absolute change from baseline. This is a 0-10 scale on which 0= no pain and 10= the worst pain imaginable.

Outcome measures

Measure	Metoclopramide n=110 Participants Metoclopramide 10mg IVSS Metoclorpamide: 10mg IVSS	Ketorolac n=110 Participants Ketorolac 30mg IV Ketorolac: 30g IVSS	Valproate n=110 Participants 1gm IV Valproate: 1gm IVSS
Headache Pain Level on a 0-10 Verbal Scale	4.7 units on a scale Interval 4.2 to 5.2	3.9 units on a scale Interval 3.3 to 4.5	2.8 units on a scale Interval 2.3 to 3.3

SECONDARY outcome

Timeframe: 2- 24 hours after receipt of medication

Population: Please note that 1 patient in the metoclopramide arm and 1 patient in the ketorolac arm were lost-to-follow-up and did not provide data for this outcome

Number of participants achieving a pain free state within two hours and maintaining the pain free state for 24 hours after receipt of medication

Outcome measures

Measure	Metoclopramide n=109 Participants Metoclopramide 10mg IVSS Metoclorpamide: 10mg IVSS	Ketorolac n=109 Participants Ketorolac 30mg IV Ketorolac: 30g IVSS	Valproate n=110 Participants 1gm IV Valproate: 1gm IVSS
Participants Who Achieve Sustained Headache Freedom for 24 Hours	12 Participants	17 Participants	4 Participants

SECONDARY outcome

Timeframe: 24 hours

Population: Study participants were telephoned 24 hours after medication administration. 3 patients in the metoclopramide arm, 4 in the ketorolac arm, and 3 in the valproate arm were lost to follow-up and did not provide these data. Additionally, 1 patient in the ketorolac arm did not provide an answer to this question

% who answer the following question affirmatively at 24 hours: Do you want to receive the same medication the next time you present to an ER with an acute migraine

Outcome measures

Measure	Metoclopramide n=107 Participants Metoclopramide 10mg IVSS Metoclorpamide: 10mg IVSS	Ketorolac n=105 Participants Ketorolac 30mg IV Ketorolac: 30g IVSS	Valproate n=107 Participants 1gm IV Valproate: 1gm IVSS
Satisfaction With Medication	65 Participants	42 Participants	28 Participants

SECONDARY outcome

Timeframe: 24 hours

Population: Any adverse event reported at any assessment throughout the study period.

% who report any adverse event after administration of investigational medication

Outcome measures

Measure	Metoclopramide n=109 Participants Metoclopramide 10mg IVSS Metoclorpamide: 10mg IVSS	Ketorolac n=110 Participants Ketorolac 30mg IV Ketorolac: 30g IVSS	Valproate n=110 Participants 1gm IV Valproate: 1gm IVSS
Adverse Event	24 Participants	33 Participants	25 Participants

Adverse Events

Metoclopramide

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Ketorolac

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Valproate

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Metoclopramide n=109 participants at risk Metoclopramide 10mg IVSS Metoclorpamide: 10mg IVSS	Ketorolac n=110 participants at risk Ketorolac 30mg IV Ketorolac: 30g IVSS	Valproate n=110 participants at risk 1gm IV Valproate: 1gm IVSS
Nervous system disorders Restless	13.8% 15/109 • Number of events 15 • Adverse events were assessed for two hours in the emergency department after medication administration and then by telephone 24 hours later. Please note: 3 patients in the metoclopramide arm, 5 in the ketorolac arm, and 3 in the valproate arm did not provide data about restlessness. Also, 1 patient in the metoclopramide arm did not provide any adverse event data. Please note: Patients who reported an adverse event but did not detail what their symptom was are counted as "other"	9.1% 10/110 • Number of events 10 • Adverse events were assessed for two hours in the emergency department after medication administration and then by telephone 24 hours later. Please note: 3 patients in the metoclopramide arm, 5 in the ketorolac arm, and 3 in the valproate arm did not provide data about restlessness. Also, 1 patient in the metoclopramide arm did not provide any adverse event data. Please note: Patients who reported an adverse event but did not detail what their symptom was are counted as "other"	8.2% 9/110 • Number of events 9 • Adverse events were assessed for two hours in the emergency department after medication administration and then by telephone 24 hours later. Please note: 3 patients in the metoclopramide arm, 5 in the ketorolac arm, and 3 in the valproate arm did not provide data about restlessness. Also, 1 patient in the metoclopramide arm did not provide any adverse event data. Please note: Patients who reported an adverse event but did not detail what their symptom was are counted as "other"
Nervous system disorders Drowsiness	1.8% 2/109 • Number of events 2 • Adverse events were assessed for two hours in the emergency department after medication administration and then by telephone 24 hours later. Please note: 3 patients in the metoclopramide arm, 5 in the ketorolac arm, and 3 in the valproate arm did not provide data about restlessness. Also, 1 patient in the metoclopramide arm did not provide any adverse event data. Please note: Patients who reported an adverse event but did not detail what their symptom was are counted as "other"	1.8% 2/110 • Number of events 2 • Adverse events were assessed for two hours in the emergency department after medication administration and then by telephone 24 hours later. Please note: 3 patients in the metoclopramide arm, 5 in the ketorolac arm, and 3 in the valproate arm did not provide data about restlessness. Also, 1 patient in the metoclopramide arm did not provide any adverse event data. Please note: Patients who reported an adverse event but did not detail what their symptom was are counted as "other"	6.4% 7/110 • Number of events 7 • Adverse events were assessed for two hours in the emergency department after medication administration and then by telephone 24 hours later. Please note: 3 patients in the metoclopramide arm, 5 in the ketorolac arm, and 3 in the valproate arm did not provide data about restlessness. Also, 1 patient in the metoclopramide arm did not provide any adverse event data. Please note: Patients who reported an adverse event but did not detail what their symptom was are counted as "other"
Nervous system disorders Dizzy	7.3% 8/109 • Number of events 8 • Adverse events were assessed for two hours in the emergency department after medication administration and then by telephone 24 hours later. Please note: 3 patients in the metoclopramide arm, 5 in the ketorolac arm, and 3 in the valproate arm did not provide data about restlessness. Also, 1 patient in the metoclopramide arm did not provide any adverse event data. Please note: Patients who reported an adverse event but did not detail what their symptom was are counted as "other"	8.2% 9/110 • Number of events 9 • Adverse events were assessed for two hours in the emergency department after medication administration and then by telephone 24 hours later. Please note: 3 patients in the metoclopramide arm, 5 in the ketorolac arm, and 3 in the valproate arm did not provide data about restlessness. Also, 1 patient in the metoclopramide arm did not provide any adverse event data. Please note: Patients who reported an adverse event but did not detail what their symptom was are counted as "other"	5.5% 6/110 • Number of events 6 • Adverse events were assessed for two hours in the emergency department after medication administration and then by telephone 24 hours later. Please note: 3 patients in the metoclopramide arm, 5 in the ketorolac arm, and 3 in the valproate arm did not provide data about restlessness. Also, 1 patient in the metoclopramide arm did not provide any adverse event data. Please note: Patients who reported an adverse event but did not detail what their symptom was are counted as "other"
Gastrointestinal disorders Dyspepsia	0.92% 1/109 • Adverse events were assessed for two hours in the emergency department after medication administration and then by telephone 24 hours later. Please note: 3 patients in the metoclopramide arm, 5 in the ketorolac arm, and 3 in the valproate arm did not provide data about restlessness. Also, 1 patient in the metoclopramide arm did not provide any adverse event data. Please note: Patients who reported an adverse event but did not detail what their symptom was are counted as "other"	3.6% 4/110 • Adverse events were assessed for two hours in the emergency department after medication administration and then by telephone 24 hours later. Please note: 3 patients in the metoclopramide arm, 5 in the ketorolac arm, and 3 in the valproate arm did not provide data about restlessness. Also, 1 patient in the metoclopramide arm did not provide any adverse event data. Please note: Patients who reported an adverse event but did not detail what their symptom was are counted as "other"	1.8% 2/110 • Adverse events were assessed for two hours in the emergency department after medication administration and then by telephone 24 hours later. Please note: 3 patients in the metoclopramide arm, 5 in the ketorolac arm, and 3 in the valproate arm did not provide data about restlessness. Also, 1 patient in the metoclopramide arm did not provide any adverse event data. Please note: Patients who reported an adverse event but did not detail what their symptom was are counted as "other"
Investigations Other	13.8% 15/109 • Number of events 15 • Adverse events were assessed for two hours in the emergency department after medication administration and then by telephone 24 hours later. Please note: 3 patients in the metoclopramide arm, 5 in the ketorolac arm, and 3 in the valproate arm did not provide data about restlessness. Also, 1 patient in the metoclopramide arm did not provide any adverse event data. Please note: Patients who reported an adverse event but did not detail what their symptom was are counted as "other"	18.2% 20/110 • Number of events 20 • Adverse events were assessed for two hours in the emergency department after medication administration and then by telephone 24 hours later. Please note: 3 patients in the metoclopramide arm, 5 in the ketorolac arm, and 3 in the valproate arm did not provide data about restlessness. Also, 1 patient in the metoclopramide arm did not provide any adverse event data. Please note: Patients who reported an adverse event but did not detail what their symptom was are counted as "other"	15.5% 17/110 • Number of events 17 • Adverse events were assessed for two hours in the emergency department after medication administration and then by telephone 24 hours later. Please note: 3 patients in the metoclopramide arm, 5 in the ketorolac arm, and 3 in the valproate arm did not provide data about restlessness. Also, 1 patient in the metoclopramide arm did not provide any adverse event data. Please note: Patients who reported an adverse event but did not detail what their symptom was are counted as "other"

Additional Information

Benjamin Friedman, MD

Albert Einstein College of Medicine, Montefiore Medical Center

Phone: 718-920-6626

Email: befriedm@montefiore.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place