Trial · NCT00680823

Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

NCT00680823, Not applicable, Completed, Robert Hickey; results first posted 2017-12-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache. Trials, record NCT00680823. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00680823

On this page

Trial

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

Title: Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache
NCT number: NCT00680823
Status: Completed
Phases: Not applicable
Enrollment: 150 participants, actual
Lead sponsor: Robert Hickey
Conditions: Headache, Migraine
Interventions: Ropivacaine, Normal saline
First posted: 2008-05-20
Last updated: 2018-02-26
Results first posted: 2017-12-13

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame
Primary	The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.	30 minutes
Secondary	Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision	3 hours
Secondary	Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study	72 hours

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.	30 minutes	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision	3 hours	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study	72 hours	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group9

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

Outcome	Group	Value	Units
The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.	Ropivacaine Injections	16	Participants
The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.	Normal Saline Injections	14	Participants
The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.	Observation	2	Participants
Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision	Ropivacaine Injections	10	Participants
Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision	Normal Saline Injections	10	Participants
Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision	Observation	12	Participants
Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study	Ropivacaine Injections	7	Participants
Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study	Normal Saline Injections	7	Participants
Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study	Observation	4	Participants

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ropivacaine Injections	50
Overall Study	STARTED	Normal Saline Injections	50
Overall Study	STARTED	Observation	50
Overall Study	COMPLETED	Ropivacaine Injections	50
Overall Study	COMPLETED	Normal Saline Injections	50
Overall Study	COMPLETED	Observation	50
Overall Study	NOT COMPLETED	Ropivacaine Injections	0
Overall Study	NOT COMPLETED	Normal Saline Injections	0
Overall Study	NOT COMPLETED	Observation	0

Source ClinicalTrials.gov

Adverse events9

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
other	pain at injection site	Musculoskeletal and connective tissue disorders	Ropivacaine Injections	16	50
other	pain at injection site	Musculoskeletal and connective tissue disorders	Normal Saline Injections	11	50
other	pain at injection site	Musculoskeletal and connective tissue disorders	Observation	0	50
other	neck pain at 3 days	Musculoskeletal and connective tissue disorders	Ropivacaine Injections	13	50
other	neck pain at 3 days	Musculoskeletal and connective tissue disorders	Normal Saline Injections	10	50
other	neck pain at 3 days	Musculoskeletal and connective tissue disorders	Observation	9	50
other	neck pain at 1 month	Musculoskeletal and connective tissue disorders	Ropivacaine Injections	12	50
other	neck pain at 1 month	Musculoskeletal and connective tissue disorders	Normal Saline Injections	5	50
other	neck pain at 1 month	Musculoskeletal and connective tissue disorders	Observation	12	50

Source ClinicalTrials.gov

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ropivacaine Injections	0	50
Total, all-cause mortality	Normal Saline Injections	0	50
Total, all-cause mortality	Observation	0	50
Total, other adverse events	Ropivacaine Injections	16	50
Total, other adverse events	Normal Saline Injections	11	50
Total, other adverse events	Observation	12	50
Total, serious adverse events	Ropivacaine Injections	0	50
Total, serious adverse events	Normal Saline Injections	0	50
Total, serious adverse events	Observation	0	50

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/NCT00680823

GET https://conductscience.org/api/trials/v1/NCT00680823/registered

API reference For AI assistants