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Efficacy of Intranasal Fentanyl at Reducing Pain During Abscess Incision and Drainage (I&D) in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Sing-Kwong Tsze, Columbia University
ClinicalTrials.gov Identifier:
NCT01549002
First received: February 2, 2012
Last updated: August 20, 2015
Last verified: August 2015
Results First Received: February 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Abscess
Pain
Interventions: Drug: Intranasal Fentanyl
Drug: Intravenous Morphine

  Participant Flow
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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
Intranasal Fentanyl

Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).

The abscess I&D will be followed according to protocol using topical and local anesthetic.

Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose

Intravenous Morphine

Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.

The abscess I&D will be followed according to protocol using topical and local anesthetic.

Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose


Participant Flow:   Overall Study
    Intranasal Fentanyl     Intravenous Morphine  
STARTED     10     10  
COMPLETED     10     6  
NOT COMPLETED     0     4  



  Baseline Characteristics
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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
Intranasal Fentanyl

Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).

The abscess I&D will be followed according to protocol using topical and local anesthetic.

Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose

Intravenous Morphine

Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.

The abscess I&D will be followed according to protocol using topical and local anesthetic.

Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose

Total Total of all reporting groups

Baseline Measures
    Intranasal Fentanyl     Intravenous Morphine     Total  
Number of Participants  
[units: participants]
  10     10     20  
Age  
[units: years]
Median (Inter-Quartile Range)
  15.3  
  (12.2 to 17.4)  
  15.4  
  (10.2 to 16.4)  
  15.4  
  (11.8 to 16.8)  
Gender  
[units: participants]
     
Female     8     7     15  
Male     2     3     5  
Observational Scale of Behavioral Distress - revised [1]
[units: units on a scale]
Mean (Standard Deviation)
  0  (0)     0  (0)     0  (0)  
[1] An observational scale of pain and distress during procedures. Scores can range from 0 to 23.5 units for each phase. A higher score indicates a greater degree of pain and distress. The total OSBD-R score is a summation of the OSBD-R score from each phase. For example, if there are six phases, the range of scores for OSBD-R is from 0 to 141. The measured baseline OSBD-R scores was ZERO for all patients.



  Outcome Measures

1.  Primary:   Score on the Observational Scale of Behavioral Distress Revised (OSBD-R)   [ Time Frame: Up to 10 minutes after the procedure completion ]

2.  Secondary:   Score on the Faces Pain Scale Revised (FPS-R)   [ Time Frame: Up to 10 minutes after procedure completion ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Score on Likert Scale for Patient Satisfaction   [ Time Frame: 10 minutes after procedure completion ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Daniel Fenster
Organization: ColumbiaU
phone: 212-305-9825
e-mail: dbf2114@columbia.edu



Responsible Party: Daniel Sing-Kwong Tsze, Columbia University
ClinicalTrials.gov Identifier: NCT01549002     History of Changes
Other Study ID Numbers: AAAI0699
Study First Received: February 2, 2012
Results First Received: February 2, 2015
Last Updated: August 20, 2015
Health Authority: United States: Institutional Review Board