Phase 3
N=49
Intranasal Fentanyl as an Adjunct to Lidocaine Infiltration in Adults Undergoing Abscess Incision and Drainage
Abscess
Bottom Line
View on ClinicalTrials.gov: NCT03872700 ↗Enrolled (actual)
49
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Numerical Rating Scale (NRS) Pain Score at Baseline — 8.3; 8.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Intranasal fentanyl (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Montefiore Medical Center
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numerical Rating Scale (NRS) Pain Score at Baseline |
8.3; 8.1 | — |
| PRIMARY NRS Pain Score After Lidocaine Injection |
8.4; 8.0 | — |
| PRIMARY NRS Pain Score Following Incision |
3.9; 3.9 | — |
| PRIMARY NRS Pain Score After Blunt Dissection |
4.1; 4.4 | — |
| PRIMARY NRS Pain Score After Irrigation |
3.4; 2.6 | — |
| PRIMARY NRS Pain Score After Packing of Abscess |
4.5; 3.9 | — |
| PRIMARY Numerical Rating Scale (NRS) Pain Score for Overall Procedure |
6.2; 7.0 | — |
| SECONDARY Patient Satisfaction With Analgesia |
1; 4; 9; 13; 14; 8 | — |
| SECONDARY Health Care Providers Reported Perception of Study Medication Compared to Usual Care |
— | — |
Summary
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).
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT03872700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.