Montefiore Medical Center
The Bronx, New York, 10467, United States
NCT Number: NCT03872700
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).
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Notify Me18 year–64 year
All sexes
Interventional
Phase 3
The Bronx, New York, 10467, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fentanyl Citrate
Sterile Water Up to 5Cc
Time frame: 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: Following Lidocaine injection measured once anytime up to 12 minutes after intranasal administration
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: Measured once anytime up to 60 minutes following intranasal administration
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
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
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 at the time of completion of application of the bandage, up to 60 minutes following intranasal administration
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.
Time frame: Measured once following placement of dressing at completion of procedure, up to 60 minutes following intranasal administration
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: 120 minutes
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
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.
Montefiore Medical Center
Other
A Randomized Trial of Intranasal Fentanyl Versus Placebo as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage in the Emergency
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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