Trial · NCT01267864

Valproate Versus Ketorolac Versus Metoclopramide

NCT01267864, Phase 4, Completed, Montefiore Medical Center; results first posted 2018-06-04

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Valproate Versus Ketorolac Versus Metoclopramide. Trials, record NCT01267864. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01267864

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Valproate Versus Ketorolac Versus Metoclopramide
NCT number: NCT01267864
Status: Completed
Phases: Phase 4
Enrollment: 330 participants, actual
Lead sponsor: Montefiore Medical Center
Conditions: Acute Migraine
Interventions: Metoclopramide, Ketorolac, Valproate
First posted: 2010-12-29
Last updated: 2018-06-04
Results first posted: 2018-06-04

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Headache Pain Level on a 0-10 Verbal Scale	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.
Secondary	Participants Who Achieve Sustained Headache Freedom for 24 Hours	2- 24 hours after receipt of medication	Number of participants achieving a pain free state within two hours and maintaining the pain free state for 24 hours after receipt of medication
Secondary	Satisfaction With Medication	24 hours	% 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
Secondary	Adverse Event	24 hours	% who report any adverse event after administration of investigational medication

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Headache Pain Level on a 0-10 Verbal Scale	60 minutes after receipt of medication		units on a scale	MEAN
SECONDARY	Participants Who Achieve Sustained Headache Freedom for 24 Hours	2- 24 hours after receipt of medication	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	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Satisfaction With Medication	24 hours	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	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Adverse Event	24 hours	Any adverse event reported at any assessment throughout the study period.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Headache Pain Level on a 0-10 Verbal Scale	Metoclopramide	4.7	95% Confidence Interval 4.2 to 5.2	units on a scale
Headache Pain Level on a 0-10 Verbal Scale	Ketorolac	3.9	95% Confidence Interval 3.3 to 4.5	units on a scale
Headache Pain Level on a 0-10 Verbal Scale	Valproate	2.8	95% Confidence Interval 2.3 to 3.3	units on a scale
Participants Who Achieve Sustained Headache Freedom for 24 Hours	Metoclopramide	12		Participants
Participants Who Achieve Sustained Headache Freedom for 24 Hours	Ketorolac	17		Participants
Participants Who Achieve Sustained Headache Freedom for 24 Hours	Valproate	4		Participants
Satisfaction With Medication	Metoclopramide	65		Participants
Satisfaction With Medication	Ketorolac	42		Participants
Satisfaction With Medication	Valproate	28		Participants
Adverse Event	Metoclopramide	24		Participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Metoclopramide	110
Overall Study	STARTED	Ketorolac	110
Overall Study	STARTED	Valproate	110
Overall Study	COMPLETED	Metoclopramide	110
Overall Study	COMPLETED	Ketorolac	110
Overall Study	COMPLETED	Valproate	110
Overall Study	NOT COMPLETED	Metoclopramide	0
Overall Study	NOT COMPLETED	Ketorolac	0
Overall Study	NOT COMPLETED	Valproate	0

Source ClinicalTrials.gov

Adverse events15

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Restless	Nervous system disorders	Metoclopramide	15	109	15
other	Restless	Nervous system disorders	Ketorolac	10	110	10
other	Restless	Nervous system disorders	Valproate	9	110	9
other	Drowsiness	Nervous system disorders	Metoclopramide	2	109	2
other	Drowsiness	Nervous system disorders	Ketorolac	2	110	2
other	Drowsiness	Nervous system disorders	Valproate	7	110	7
other	Dizzy	Nervous system disorders	Metoclopramide	8	109	8
other	Dizzy	Nervous system disorders	Ketorolac	9	110	9
other	Dizzy	Nervous system disorders	Valproate	6	110	6
other	Dyspepsia	Gastrointestinal disorders	Metoclopramide	1	109

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Metoclopramide
Total, all-cause mortality	Ketorolac
Total, all-cause mortality	Valproate
Total, other adverse events	Metoclopramide	24	109
Total, other adverse events	Ketorolac	33	110
Total, other adverse events	Valproate	25	110
Total, serious adverse events	Metoclopramide	0	109
Total, serious adverse events	Ketorolac	0	110
Total, serious adverse events	Valproate	0	110

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01267864

GET https://conductscience.org/api/trials/v1/NCT01267864/registered

API reference For AI assistants