Nasogastric Tube Insertion Using Midazolam in the Emergency Department (NIMED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kalev Freeman, University of Vermont
ClinicalTrials.gov Identifier:
NCT01375634
First received: June 3, 2011
Last updated: July 19, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Intubation; Difficult
Drug: Midazolam
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Nasogastric Tube Insertion Using Midazolam in the Emergency Department

Resource links provided by NLM:


Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Pain score on the visual analog scale reported by patient [ Time Frame: Within 30 minutes after completion of procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: Within 30 minutes after completion of procedure ] [ Designated as safety issue: No ]
    Degree of discomfort reported by subject on a visual analog scale and a five point scale


Secondary Outcome Measures:
  • Difficulty of tube placement [ Time Frame: Within 30 minutes after completion of procedure ] [ Designated as safety issue: No ]
    Difficulty of nasogastric tube insertion as reported by RN on a five point scale

  • Complications [ Time Frame: Within 30 minutes after completion of procedure ] [ Designated as safety issue: Yes ]
    Number of complications as evaluated by RN, including vomiting, epistaxis or other bleeding, gagging/choking, tracheal misplacement or knotting/kinking/coiling of tube.


Enrollment: 49
Study Start Date: May 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Normal saline
Drug: Midazolam
2 mg intravenous over 2 minutes For patients >60 years of age or with history of pulmonary disease, 1 mg intravenous over 2 minutes
Other Name: Versed
Experimental: Midazolam
Midazolam
Drug: Midazolam
2 mg intravenous over 2 minutes For patients >60 years of age or with history of pulmonary disease, 1 mg intravenous over 2 minutes
Other Name: Versed

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375634

Locations
United States, Vermont
Fletcher Allen Health Care Emergency Department
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
Investigators
Principal Investigator: Kalev Freeman, MD, PhD University of Vermont
  More Information

Additional Information:
Publications:
Responsible Party: Kalev Freeman, Assistant Professor, University of Vermont
ClinicalTrials.gov Identifier: NCT01375634     History of Changes
Other Study ID Numbers: CHRMS:M11-131-NIMED
Study First Received: June 3, 2011
Last Updated: July 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Vermont:
Intubation
Gastrointestinal

Additional relevant MeSH terms:
Midazolam
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 16, 2014