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Completed

NCT Number: NCT03872700

Intranasal Fentanyl as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage

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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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Presenting to the ED for an abscess requiring incision and drainage
  • ED attending physician's judgment that the patient has capacity to provide informed consent.
  • Patients must be able to understand English or Spanish.

Exclusion criteria

  • Use of opioids or tramadol within past 7 days.
  • Prior adverse reaction or allergy to opioids.
  • Patients who are pregnant
  • Patients weight > 100kg
  • Chronic pain syndrome: frequently recurrent or daily pain for at least 3 months results in modulation of pain perception which is thought to be due to down-regulation of pain receptors. Examples of chronic pain syndromes include sickle cell anemia, osteoarthritis, fibromyalgia, and peripheral neuropathies.
  • Medical condition that might affect metabolism or opioid analgesics such as cirrhosis (Child Pugh A or worse) or kidney impairment (CKD 3 or worse)
  • Chronic malnutrition, severe hypovolemia (dehydration of blood loss) or hepatic disease
  • Alcohol intoxication: history of alcoholism or the presence of alcohol intoxication as judged by the treating physician may alter pain perception and has previously increased adverse events.
  • SBP <100 mmHg: Opioids can produce peripheral vasodilation causing orthostasis.
  • HR < 60/min: Opioids can cause bradycardia.
  • Oxygen saturation < 95% on room air: For this study, oxygen saturation must be 95% or above on room air in order to be enrolled.
  • Use of MAO inhibitors in past 30 days: MAO inhibitors have been reported to intensify the effects of at least one opioid drug causing anxiety, confusion and significant respiratory depression or coma.
  • Patients using transdermal pain patches or oral opioid use > 10 days in the prior month: frequent opioid use may influence both the amount of pain patients report as well as the level of relief they obtain from other treatments.
  • Patients with a history of traumatic brain injury, seizures or hallucinations
  • Patients with anatomical anomalies or medical conditions precluding intranasal administration

Treatment and study plan

Intranasal Fentanyl

Drug

Fentanyl Citrate

Placebo

Drug

Sterile Water Up to 5Cc

Primary outcomes

  1. Numerical Rating Scale (NRS) Pain Score at Baseline

    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.

  2. NRS Pain Score After Lidocaine Injection

    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.

  3. NRS Pain Score Following Incision

    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.

  4. NRS Pain Score After Blunt Dissection

    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.

  5. NRS Pain Score After Irrigation

    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.

  6. NRS Pain Score After Packing of Abscess

    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.

  7. Numerical Rating Scale (NRS) Pain Score for Overall Procedure

    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.

Secondary outcomes

  1. Patient Satisfaction With Analgesia

    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.

  2. Health Care Providers Reported Perception of Study Medication Compared to Usual Care

    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.

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

A Randomized Trial of Intranasal Fentanyl Versus Placebo as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage in the Emergency

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Mar 13, 2019
Registry last updated
Aug 15, 2023

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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