Nasogastric Tube Insertion Using Midazolam in the Emergency Department (NIMED)
Primary Purpose
Intubation; Difficult
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Midazolam
Sponsored by

About this trial
This is an interventional supportive care trial for Intubation; Difficult focused on measuring Intubation, Gastrointestinal
Eligibility Criteria
Inclusion Criteria:
- at least 18 years old
- Receiving a nasogastric tube by a registered nurse at Fletcher Allen Health Care
Exclusion Criteria:
- less than 18 years old
- weight < 40 kg
- Need immediate nasogastric tube placement
- Endotracheal intubation
- Hemodynamically unstable
- Non-English speaking
- Without capacity to provide informed consent
Sites / Locations
- Fletcher Allen Health Care Emergency Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Midazolam
Arm Description
Normal saline
Midazolam
Outcomes
Primary Outcome Measures
Pain score on the visual analog scale reported by patient
Degree of pain reported by subject on a visual analog scale and a five point scale
Discomfort score on the visual analog scale reported by patient
Degree of discomfort reported by subject on a visual analog scale and a five point scale
Secondary Outcome Measures
Difficulty of tube placement
Difficulty of nasogastric tube insertion as reported by RN on a five point scale
Complications
Number of complications as evaluated by RN, including vomiting, epistaxis or other bleeding, gagging/choking, tracheal misplacement or knotting/kinking/coiling of tube.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01375634
Brief Title
Nasogastric Tube Insertion Using Midazolam in the Emergency Department
Acronym
NIMED
Official Title
Nasogastric Tube Insertion Using Midazolam in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Vermont
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Nasogastric tube placement involves insertion of a flexible tube through the nose into the stomach. Placement of the tube can irritate the nose and palate and trigger gagging, causing discomfort, even if topical or local anesthetics are used. This study aims to determine if administration of an ultra-short acting sedative agent (midazolam) into a vein before the procedure, in addition to topical local anesthetic, will decrease the level of discomfort.
Detailed Description
Our overall objective is to improve patient satisfaction with nasogastric (NG) tube placement (placement of a flexible tube through the nose into the stomach) in the emergency department. Placement of an NG tube into the stomach is often performed in the emergency department (ED) setting to evacuate air, blood, or other contents. Generally performed by nursing staff at the bedside in the emergency department, the procedure may produce significant pain and discomfort for the patient despite typical measures including local medications to constrict and numb the nasal mucosa. In one questionnaire of emergency department patients at a large university hospital, placement of an NG tube was reported to be the most painful procedure, ahead of fracture reduction, abscess drainage, and urethral catheterization (Singer et al. 1999). The typical medication used for placement of an NG tube placement is administration of local, topical medications; the use of intravenous drugs to improve patient tolerance of the procedure varies widely in clinical practice (Juhl and Conners 2005). Midazolam (Versed) is an FDA-approved agent for procedural sedation, which has been used frequently at this institution for the placement of NG tubes in the emergency department. In our experience, it facilitates placement by relaxing muscles, thereby decreasing gag, and its anxiolytic and amnestic properties improve patient satisfaction. However, there are no published studies of midazolam for NG tube placement in the ED or any other setting.
The investigators will perform a randomized controlled trial to determine if a single 2mg unit midazolam dose administered intravenously decreases discomfort for patients undergoing nasogastric tube placement in the emergency department. Adult emergency department patients who require NG tubes will be screened and following informed consent they will be randomly assigned to receive either midazolam or saline control. Medications are provided by pharmacy. Registered nurses will perform the placement and administer medications; researcher, nurse and subject will be blinded to the treatment arm. Following the procedure, subjects will be asked to assess their level of discomfort and complete a brief researcher-assisted questionnaire about their experience. The nurse will also complete a questionnaire that addresses the difficulty of the procedure, level of success, and occurrence of unanticipated problems or adverse events. This study may provide support for a clinical practice to improve care for patients requiring NG tube placement in the ED.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intubation; Difficult
Keywords
Intubation, Gastrointestinal
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline
Arm Title
Midazolam
Arm Type
Experimental
Arm Description
Midazolam
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Versed
Intervention Description
2 mg intravenous over 2 minutes For patients >60 years of age or with history of pulmonary disease, 1 mg intravenous over 2 minutes
Primary Outcome Measure Information:
Title
Pain score on the visual analog scale reported by patient
Description
Degree of pain reported by subject on a visual analog scale and a five point scale
Time Frame
Within 30 minutes after completion of procedure
Title
Discomfort score on the visual analog scale reported by patient
Description
Degree of discomfort reported by subject on a visual analog scale and a five point scale
Time Frame
Within 30 minutes after completion of procedure
Secondary Outcome Measure Information:
Title
Difficulty of tube placement
Description
Difficulty of nasogastric tube insertion as reported by RN on a five point scale
Time Frame
Within 30 minutes after completion of procedure
Title
Complications
Description
Number of complications as evaluated by RN, including vomiting, epistaxis or other bleeding, gagging/choking, tracheal misplacement or knotting/kinking/coiling of tube.
Time Frame
Within 30 minutes after completion of procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
at least 18 years old
Receiving a nasogastric tube by a registered nurse at Fletcher Allen Health Care
Exclusion Criteria:
less than 18 years old
weight < 40 kg
Need immediate nasogastric tube placement
Endotracheal intubation
Hemodynamically unstable
Non-English speaking
Without capacity to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kalev Freeman, MD, PhD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fletcher Allen Health Care Emergency Department
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15278085
Citation
Cullen L, Taylor D, Taylor S, Chu K. Nebulized lidocaine decreases the discomfort of nasogastric tube insertion: a randomized, double-blind trial. Ann Emerg Med. 2004 Aug;44(2):131-7. doi: 10.1016/j.annemergmed.2004.03.033.
Results Reference
background
PubMed Identifier
15788820
Citation
Juhl GA, Conners GP. Emergency physicians' practices and attitudes regarding procedural anaesthesia for nasogastric tube insertion. Emerg Med J. 2005 Apr;22(4):243-5. doi: 10.1136/emj.2004.015602.
Results Reference
background
PubMed Identifier
10339680
Citation
Singer AJ, Richman PB, Kowalska A, Thode HC Jr. Comparison of patient and practitioner assessments of pain from commonly performed emergency department procedures. Ann Emerg Med. 1999 Jun;33(6):652-8.
Results Reference
background
Links:
URL
http://www.uvm.edu/medicine/freemanlab/?Page=em_research.html
Description
Emergency Medicine Research at UVM and FAHC
Learn more about this trial
Nasogastric Tube Insertion Using Midazolam in the Emergency Department
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