Nasogastric Tube Insertion Using Midazolam in the Emergency Department

NCT01375634 | Completed Phase 4

• 1 other identifier: CHRMS:M11-131-NIMED
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation; Difficult

Keywords

Intubation; Gastrointestinal

Outcome Measures

Primary Outcomes (2)

• 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

  Within 30 minutes after completion of procedure

• 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

  Within 30 minutes after completion of procedure

Secondary Outcomes (2)

• Difficulty of tube placement

  Within 30 minutes after completion of procedure

• Complications

  Within 30 minutes after completion of procedure

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Normal saline

Drug: Midazolam

Midazolam

EXPERIMENTAL

Midazolam

Drug: Midazolam

Interventions

Midazolam 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

Also known as: Versed

Midazolam; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• at least 18 years old
• Receiving a nasogastric tube by a registered nurse at Fletcher Allen Health Care

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (1)

Fletcher Allen Health Care Emergency Department

Burlington, Vermont, 05401, United States

Location

Related Publications (3)

• 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.

  PMID: 15278085 BACKGROUND

• 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.

  PMID: 15788820 BACKGROUND

• 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.

  PMID: 10339680 BACKGROUND

Related Links

• Emergency Medicine Research at UVM and FAHC

MeSH Terms

Interventions

Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kalev Freeman, MD, PhD

  University of Vermont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 3, 2011
• First Posted: June 17, 2011
• Study Start: May 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 22, 2013

Record last verified: 2013-07

Locations

US (1)