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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 : December 13, 2017
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Ropivacaine Injections   Normal Saline Injections   Observation
STARTED   50   50   50 
COMPLETED   50   50   50 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
   Ropivacaine Injections   Normal Saline Injections   Observation   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   50   50   150 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Mean (Standard Deviation)
 14  (2)   14  (2)   15  (2)   14  (2) 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: Participants]
       
United States   50   50   50   150 


  Outcome Measures

1.  Primary:   The Primary Outcome Will be Pain Relief Sufficient for Discharge From the Emergency Department.   [ Time Frame: 3 hours ]

2.  Secondary:   Complete Resolution of Headache   [ Time Frame: 3 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Admission   [ Time Frame: 3 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Time From Presentation to Ultimate Disposition   [ Time Frame: 3 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Re-presentation to the Emergency Department With Headache Within 72 Hours of Participating in the Study   [ Time Frame: 72 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   a Change of Greater Than 1.5 on the Numerical Rating Scale   [ Time Frame: 3 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: robert.hickey@chp.edu



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: December 13, 2017