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Study of Intramuscular Ropivacaine Injections for Treatment of Pediatric Headache

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ClinicalTrials.gov Identifier: NCT00680823
Recruitment Status : Completed
First Posted : May 20, 2008
Results First Posted : December 13, 2017
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Robert Hickey, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Headache
Migraine
Interventions Drug: Ropivacaine
Drug: Normal saline
Enrollment 150
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ropivacaine Injections Normal Saline Injections Observation
Hide Arm/Group Description

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.

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 for 30 minutes.
Period Title: Overall Study
Started 50 50 50
Completed 50 50 50
Not Completed 0 0 0
Arm/Group Title Ropivacaine Injections Normal Saline Injections Observation Total
Hide Arm/Group Description

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.

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 for 30 minutes. Total of all reporting groups
Overall Number of Baseline Participants 50 50 50 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 50 participants 150 participants
<=18 years
50
 100.0%
50
 100.0%
50
 100.0%
150
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 50 participants 50 participants 150 participants
14  (2) 14  (2) 15  (2) 14  (2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 50 participants 50 participants 150 participants
Female
38
  76.0%
38
  76.0%
38
  76.0%
114
  76.0%
Male
12
  24.0%
12
  24.0%
12
  24.0%
36
  24.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 50 participants 50 participants 50 participants 150 participants
50 50 50 150
1.Primary Outcome
Title The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.
Hide Description [Not Specified]
Time Frame 30 minutes
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ropivacaine Injections Normal Saline Injections Observation
Hide Arm/Group Description:

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.

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 for 30 minutes.
Overall Number of Participants Analyzed 50 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
16
  32.0%
14
  28.0%
2
   4.0%
2.Secondary Outcome
Title Number and Percent of Patients Admitted to the Hospital for Additional Therapy in Each Treatment Arm Based Upon Treating Clinicians Decision
Hide Description [Not Specified]
Time Frame 3 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ropivacaine Injections Normal Saline Injections Observation
Hide Arm/Group Description:

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.

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 for 30 minutes.
Overall Number of Participants Analyzed 50 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
10
  20.0%
10
  20.0%
12
  24.0%
3.Secondary Outcome
Title Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study
Hide Description [Not Specified]
Time Frame 72 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ropivacaine Injections Normal Saline Injections Observation
Hide Arm/Group Description:

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.

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 for 30 minutes.
Overall Number of Participants Analyzed 50 50 50
Measure Type: Count of Participants
Unit of Measure: Participants
7
  14.0%
7
  14.0%
4
   8.0%
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ropivacaine Injections Normal Saline Injections Observation
Hide Arm/Group Description

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.

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 for 30 minutes.
All-Cause Mortality
Ropivacaine Injections Normal Saline Injections Observation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%)   0/50 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Ropivacaine Injections Normal Saline Injections Observation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/50 (0.00%)   0/50 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ropivacaine Injections Normal Saline Injections Observation
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   16/50 (32.00%)   11/50 (22.00%)   12/50 (24.00%) 
Musculoskeletal and connective tissue disorders       
pain at injection site   16/50 (32.00%)  11/50 (22.00%)  0/50 (0.00%) 
neck pain at 3 days   13/50 (26.00%)  10/50 (20.00%)  9/50 (18.00%) 
neck pain at 1 month   12/50 (24.00%)  5/50 (10.00%)  12/50 (24.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Robert Hickey
Organization: Children's Hospital of Pittsburgh
Phone: 412 692 7692
Responsible Party: Robert Hickey, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00680823     History of Changes
Other Study ID Numbers: PRO08030283
First Submitted: May 16, 2008
First Posted: May 20, 2008
Results First Submitted: November 16, 2017
Results First Posted: December 13, 2017
Last Update Posted: February 26, 2018