Abscess Clinical Trial
Official title:
Adjunctive Nitrous Oxide During Emergency Department Propofol Sedation in Adults, a Pilot Study
NCT number | NCT02410707 |
Other study ID # | HN4641 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2015 |
Est. completion date | February 2018 |
Verified date | March 2020 |
Source | Albert Einstein Healthcare Network |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to describe the safety and efficacy of nitrous oxide administration for pain and anxiety before propofol in patients requiring any procedure under sedation in the Emergency Department. Procedural sedation is the use of sedative, analgesic, and/or dissociative agents to relieve anxiety and pain associated with diagnostic and therapeutic procedures. Propofol is commonly used and is a sedative and amnestic, but provides no analgesia. Short acting opioids may be used for pain relief, but come with the risk of respiratory depression. An optimum analgesic to relieve pain in patients who need procedural sedation should be short acting, easy to administer and safe. Nitrous oxide may be a suitable agent, but literature supporting or rejecting its use in adults is lacking. This study aims to fill this gap. Adult patients capable of consenting, coming to the Emergency Department with painful condition requiring procedural sedation are the targeted population. Eligible patients who consent to the study will receive Nitrous Oxide gas delivered through a hand held mask before they receive propofol for the procedure. Information regarding their vitals, pain scores and medical condition will also be collected.
Status | Completed |
Enrollment | 43 |
Est. completion date | February 2018 |
Est. primary completion date | February 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Spontaneous respirations - 18 years of age and older - American Society of Anesthesiologists (ASA) Physical Status Classification 1 or 2, who will be receiving sedation for an Emergency Department procedure. - Ability to provide informed consent. Exclusion Criteria: - Comorbidities that affect ventilation, perfusion, or metabolism - Intubated - Cardiopulmonary instability - Major trauma - Sepsis - American Society of Anesthesiologists (ASA) class 3, 4, and 5. - Inability to provide informed consent - Nursing home residents - Age less than 18 years - Non English speaking - Pregnant women - Under police custody |
Country | Name | City | State |
---|---|---|---|
United States | Albert Einstein Medical Center | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Albert Einstein Healthcare Network |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Number of Respiratory Depression Events | End tidal CO2 and SpO2 measured every 20 milliseconds seconds captured by a monitoring device. Events of respiratory depression are defined as peripheral SaO2 below 92%, ETCO2 level above 50, a rise or decrease of 10% above or below baseline, and/or the loss of the ETCO2 waveform for more than 15 seconds | day 1 | |
Secondary | Total Number of Airway Repositioning Events | Presence or absence of physician intervention requiring airway repositioning by provider due to decreased oxygen saturation less than 92% | day 1 | |
Secondary | Total Number of Events Requiring Additional Oxygen | Presence or absence of physician intervention requiring additional oxygen via nasal cannula or non rebreather by the provider due to oxygen saturation less than 92% | day 1 | |
Secondary | Total Number of Positive Pressure Ventilation Events | Presence or absence of physician intervention requiring positive pressure ventilation via a bag valve max due to decreased oxygen saturation less than 92% | day 1 | |
Secondary | Total Number of Endotracheal Intubation Events | Presence or absence of physician intervention requiring endotracheal intubation by provider due to decreased oxygen saturation less than 92% | day 1 | |
Secondary | Total Number of Physical Stimulation Events | Presence or absence of physician intervention requiring physical stimulation by the provider due to decreased oxygen saturation less than 92% | day 1 | |
Secondary | Patient, Physician, and Nurse Satisfaction Surveys | Patient satisfaction with use of Nitrous Oxide in anxiolysis and pain control | day 1 | |
Secondary | Post-Procedure VAS Pain Score | Visual Analog Scale (0-100mm), where 0 mm is minimum pain, and 100 mm is maximum pain. | day 1 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03127371 -
Adjunctive Nitrous Oxide During ED Incision and Drainage of Abscess
|
N/A | |
Completed |
NCT02240498 -
Safety and Feasibility Study of Methylene Blue Photodynamic Therapy to Sterilize Deep Tissue Abscess Cavities
|
Phase 1 | |
Completed |
NCT00746109 -
Study of Wound Packing After Superficial Skin Abscess Drainage
|
Phase 4 | |
Completed |
NCT00352612 -
Comparison of Cephalexin Versus Clindamycin for Suspected CA-MRSA Skin Infections
|
Phase 4 | |
Completed |
NCT00402727 -
Comparison of Sequential IV/PO Moxifloxacin With IV Piperacillin/Tazobactam Followed by PO Amoxicillin/Clavulanic Acid in Patients With a Complicated Skin and Skin Structure Infection
|
Phase 3 | |
Completed |
NCT00137085 -
Ketamine Versus Fentanyl as an Adjunct to Propofol-Assisted Emergency Department Procedural Sedation
|
N/A | |
Completed |
NCT02714023 -
Water And Saline Head-to-head In The Blinded Evaluation Study Trial
|
N/A | |
Completed |
NCT02264392 -
US Guided Versus BlindI&D for Treatment of Soft Tissue Abscesses in the ED
|
N/A | |
Active, not recruiting |
NCT05226260 -
Decreasing Antibiotic Duration for Skin and Soft Tissue Infection Using Behavioral Economics in Primary Care
|
N/A | |
Withdrawn |
NCT04241471 -
Incision and Loop Drainage Utilizing a Novel Technique for Management of Cutaneous Abscess in an Adult Population
|
N/A | |
Recruiting |
NCT06284473 -
Ketamine as a Supplement to Local Anesthesia for Minor Procedures
|
Phase 4 | |
Completed |
NCT01235546 -
Study of Effectiveness and Safety of Azithromycin-based Extended-spectrum Prophylaxis to Prevent Post Cesarean Infection
|
N/A | |
Withdrawn |
NCT00900510 -
Antibiotic Therapy After Incision and Drainage for Abscess
|
N/A | |
Not yet recruiting |
NCT03917134 -
Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess After Laparoscopic Hysterectomy
|
N/A | |
Withdrawn |
NCT02703233 -
Effectiveness of Nitrous Oxide in the ED
|
Phase 4 | |
Completed |
NCT01557426 -
Soft Tissue Ultrasound of Infections
|
Phase 1 | |
Completed |
NCT01339091 -
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
|
Phase 3 | |
Completed |
NCT01784458 -
Clinical Significance of Intra-abdominal Hypertension in Surgical Patients With Severe Sepsis
|
N/A | |
Terminated |
NCT00867789 -
Antibiotics Versus Placebo in the Treatment of Abscesses in the Emergency Department
|
N/A | |
Completed |
NCT00984022 -
Aquacel Versus Iodoform Gauze for Filling Abscess Cavity Following Incision and Drainage
|
Phase 2 |