This randomized clinical trial aims to compare the analgesic efficacy of intranasal fentanyl to placebo as analgesic adjunct to conventional local anesthesia for the treatment of pain of the overall procedure in adult patients undergoing lidocaine infiltration and subsequent abscess incision and drainage in the Emergency Department (ED).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
49
Fentanyl Citrate
Sterile Water Up to 5Cc
Montefiore Medical Center
The Bronx, New York, United States
Numerical Rating Scale (NRS) Pain Score at Baseline
Patient reported pain scores at baseline. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.
Time frame: Baseline
NRS Pain Score After Lidocaine Injection
Patient reported NRS pain scores after Lidocaine injection. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.
Time frame: Following Lidocaine injection measured once anytime up to 12 minutes after intranasal administration
NRS Pain Score Following Incision
Patient reported NRS pain scores following Incision. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.
Time frame: Measured once anytime up to 60 minutes following intranasal administration
NRS Pain Score After Blunt Dissection
Patient reported NRS pain scores after Blunt Dissection. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.
Time frame: Measured once anytime up to 60 minutes following intranasal administration
NRS Pain Score After Irrigation
Patient reported NRS pain scores after Irrigation. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.
Time frame: Measured once anytime up to 60 minutes following intranasal administration
NRS Pain Score After Packing of Abscess
Patient reported pain after Packing of abscess. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.
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Time frame: Measured once at the time of completion of application of the bandage, up to 60 minutes following intranasal administration
Numerical Rating Scale (NRS) Pain Score for Overall Procedure
Patient reported pain scores for overall Procedure assessed immediately after placement of dressing at the end of procedure. The NRS for pain is a reliable and validated measure of pain intensity ranging from 0 - no pain, to 10 - worst pain imaginable.
Time frame: Measured once following placement of dressing at completion of procedure, up to 60 minutes following intranasal administration
Patient Satisfaction With Analgesia
Patient reported outcomes were measured and reported using the Descriptive Scale below: Descriptive Scale: satisfied with analgesia, neutral, not satisfied with analgesia \*This is a non-numerical scale with 3 outcome response options as listed above. Satisfied is rated higher than neutral which is, in turn, rated higher than not satisfied.
Time frame: 120 minutes
Health Care Providers Reported Perception of Study Medication Compared to Usual Care
Provider perception of better, same or worse treatment compared to usual care Descriptive Scale: better, same, worse \*This is a non-numerical scale with 3 outcome response options as listed above. Better is rated higher than same which is, in turn, rated higher than worse.
Time frame: 120 minutes