Nasogastric Tube Insertion Using Midazolam in the Emergency Department

NCT ID: NCT01375634

Last Updated: 2013-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-04-30

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.

Conditions

Intubation; Difficult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Normal saline

Group Type: PLACEBO_COMPARATOR

Midazolam

Intervention Type: DRUG

2 mg intravenous over 2 minutes For patients \>60 years of age or with history of pulmonary disease, 1 mg intravenous over 2 minutes

Midazolam

Midazolam

Group Type: EXPERIMENTAL

Midazolam

Intervention Type: DRUG

2 mg intravenous over 2 minutes For patients \>60 years of age or with history of pulmonary disease, 1 mg intravenous over 2 minutes

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Versed

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Vermont

OTHER

Sponsor Role: lead

Responsible Party

Kalev Freeman

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kalev Freeman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Vermont

Locations

Fletcher Allen Health Care Emergency Department

Burlington, Vermont, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 15278085 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15788820 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10339680 (View on PubMed)

Related Links

http://www.uvm.edu/medicine/freemanlab/?Page=em_research.html

Emergency Medicine Research at UVM and FAHC

Other Identifiers

CHRMS:M11-131-NIMED

Identifier Type: -

Identifier Source: org_study_id