Naloxegol to Prevent Lower Gastrointestinal Paralysis in Critically Ill Adults Administered Opioids

Summary

This study evaluates the addition of naloxegol (Movantik) to a laxative protocol in critically ill adults requiring scheduled opioid (e.g. fentanyl) therapy. Half of the participants will receive naloxegol and a laxative protocol and half the participants will receive a placebo and a laxative protocol.

Conditions

• Constipation

Interventions

DRUG

Naloxegol Oral Tablet

Naloxegol Oral Tablet 25 mg (or 12.5 mg) po (enteral) daily

DRUG

Placebo Oral Tablet

Placebo Oral Tablet po (enteral) twice daily

DRUG

Docusate Sodium 100 Mg oral capsule [Colace]

Docusate Sodium 100 mg po (enteral) twice daily

DRUG

Senna 217 Mg Oral Tablet

Senna 127 mg oral tablet daily if no spontaneous bowel movement \>/=3 days after scheduled opioid initiation; increase to two senna 127 mg tables if no no spontaneous bowel movement \>/=4 days after scheduled opioid initiation. Repeat two senna 127 mg tablets if no spontaneous bowel movement \>/=5 days after scheduled opioid initiation. Repeat two senna 127 mg tablets if no spontaneous bowel movement \>/=6 days after scheduled opioid initiation.

DRUG

Polyethylene Glycols

Polyethylene Glycols 17 g daily if no spontaneous bowel movement \>/=3 days after scheduled opioid initiation; increase to 34 g daily if no spontaneous bowel movement \>/=4 days after scheduled opioid initiation. Repeat 34 g daily if no spontaneous bowel movement \>/= 5 days after scheduled opioid initiation. Repeat 34 g daily if no spontaneous bowel movement \>/= 6 days after scheduled opioid initiation.

DRUG

Bisacodyl 10 mg Suppository

Insert one suppository if no spontaneous bowel movement \>/=4 days after scheduled opioid initiation. Repeat if no spontaneous bowel movement \>/= 5 days after scheduled opioid initiation. Repeat if no spontaneous bowel movement \>/= 6 days after scheduled opioid initiation.

DRUG

Magnesium Citrate Oral Liquid Product

Administer one 10 oz bottle if no spontaneous bowel movement \>/= 5 days after scheduled opioid initiation.

DRUG

Methylnaltrexone

Administer 8 mg or 16 mg (depending on subject's weight) subcutaneously x 1 if no spontaneous bowel movement \>/= 6 days after scheduled opioid initiation, consult surgery/gastroenterology and discontinue study medication.

Sponsors & Collaborators

• Tufts Medical Center

  lead OTHER

Principal Investigators

• Erik Garpestad, MD · Tufts Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-01-01

Primary Completion

2019-10-09

Completion

2019-10-09

Countries

• United States

Study Locations