Trial Outcomes & Findings for Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache (NCT NCT00680823)

NCT ID: NCT00680823

Last Updated: 2018-02-26

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 150 participants
• Primary outcome timeframe: 30 minutes
• Results posted on: 2018-02-26

Participant Flow

Participant milestones

Measure	Ropivacaine Injections Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side. Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.	Normal Saline Injections Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side. Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.	Observation Observation for 30 minutes.
Overall Study STARTED	50	50	50
Overall Study COMPLETED	50	50	50
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

Baseline characteristics by cohort

Measure	Ropivacaine Injections n=50 Participants Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side. Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.	Normal Saline Injections n=50 Participants Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side. Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.	Observation n=50 Participants Observation for 30 minutes.	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	50 Participants n=93 Participants	50 Participants n=4 Participants	50 Participants n=27 Participants	150 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Continuous	14 years STANDARD_DEVIATION 2 • n=93 Participants	14 years STANDARD_DEVIATION 2 • n=4 Participants	15 years STANDARD_DEVIATION 2 • n=27 Participants	14 years STANDARD_DEVIATION 2 • n=483 Participants
Sex: Female, Male Female	38 Participants n=93 Participants	38 Participants n=4 Participants	38 Participants n=27 Participants	114 Participants n=483 Participants
Sex: Female, Male Male	12 Participants n=93 Participants	12 Participants n=4 Participants	12 Participants n=27 Participants	36 Participants n=483 Participants
Region of Enrollment United States	50 participants n=93 Participants	50 participants n=4 Participants	50 participants n=27 Participants	150 participants n=483 Participants

PRIMARY outcome

Timeframe: 30 minutes

Outcome measures

Measure	Ropivacaine Injections n=50 Participants Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side. Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.	Normal Saline Injections n=50 Participants Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side. Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.	Observation n=50 Participants Observation for 30 minutes.
The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.	16 Participants	14 Participants	2 Participants

SECONDARY outcome

Timeframe: 3 hours

Outcome measures

Measure	Ropivacaine Injections n=50 Participants Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side. Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.	Normal Saline Injections n=50 Participants Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side. Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.	Observation n=50 Participants Observation for 30 minutes.
Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision	10 Participants	10 Participants	12 Participants

SECONDARY outcome

Timeframe: 72 hours

Outcome measures

Measure	Ropivacaine Injections n=50 Participants Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side. Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.	Normal Saline Injections n=50 Participants Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side. Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.	Observation n=50 Participants Observation for 30 minutes.
Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study	7 Participants	7 Participants	4 Participants

Adverse Events

Ropivacaine Injections

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Normal Saline Injections

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Observation

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ropivacaine Injections n=50 participants at risk Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of 0.5% ropivacaine on each side. Ropivacaine: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.	Normal Saline Injections n=50 participants at risk Intramuscular injection of the lower cervical paraspinous muscles with 1.5 mL of normal saline on each side. Normal saline: 1.5 mL IM to each side in to the lower cervical paraspinous muscles x 1.	Observation n=50 participants at risk Observation for 30 minutes.
Musculoskeletal and connective tissue disorders pain at injection site	32.0% 16/50 • 1 month	22.0% 11/50 • 1 month	0.00% 0/50 • 1 month
Musculoskeletal and connective tissue disorders neck pain at 3 days	26.0% 13/50 • 1 month	20.0% 10/50 • 1 month	18.0% 9/50 • 1 month
Musculoskeletal and connective tissue disorders neck pain at 1 month	24.0% 12/50 • 1 month	10.0% 5/50 • 1 month	24.0% 12/50 • 1 month

Additional Information

Dr. Robert Hickey

Children's Hospital of Pittsburgh

Phone: 412 692 7692

Email: robert.hickey@chp.edu

Results disclosure agreements

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