Opioid Withdrawal Symptoms in Critically Ill Patients

Critical Illness Clinical Trial

Official title:

Opioid Withdrawal Symptoms in Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03374722
• Other study ID #: 10-60-68
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: October 7, 2018

Study information

• Verified date: October 2018
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Most critically ill patients encounter pain and distress from acute illness, medical procedures and devices as well as routine care in the intensive care units (ICU). Opioids are principal analgesics that alleviate moderate to severe pain and facilitate patients to co-operate the course of treatment. However, prolong administration of opioids especially in mechanically ventilated patients can cause withdrawal symptoms if analgesics are rapidly weaning or acutely disruption. The opioid withdrawal symptoms (OWS) are well reported in critically ill children that cause discomfort and prolong weaning from mechanical ventilation. Weaning opioids and treatment of withdrawal symptoms are needed in order to decrease ventilator days, ICU and hospital length of stay. Conversely, there is lack of knowledge about incidence, clinical presentation, time course and appropriated assessment tool for withdrawal detection. Therefore, we conduct the study to explore an incidence of OWS, to identify factors associated OWS, to establish the assessment tool for OWS, and to report efficacy of the pharmacological treatment for OWS, in adult critically ill patients.

Description:

The primary objective of the study is to explore incidence of OWS in adult critically ill patients. The secondary objectives are 1) to identify factor associated OWS, 2) establish the assessment tool for OWS for adults and 3) to report efficacy of the pharmacological treatment in OWS in adults patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: October 7, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Age =18 years

• On mechanical ventilator at least 24 hours

• Received continuous infusion of opioid at least 24 hours

• Patient or legal surrogate who is willing and able to provide written informed consent and comply with all protocol requirements

Exclusion Criteria:

• Severely disturbed behavior pattern on account of underlying neurological disease (status epilepticus, encephalopathy, head trauma, brain injury, spinal cord injury)

• Preexisting psychiatric diagnosis

• Substance abuse prior to ICU admission

• Chronic alcohol drinking

• Pregnancy

• End-of-life care

• Death during ICU admission or during opioid IV infusion

Related Conditions & MeSH terms

• Critical Illness
• Substance Withdrawal Syndrome

Intervention

Drug:
• Opioids
Mechanically ventilated critically ill patients who receive continuous opioid infusion for more than 24 hours will be observed for withdrawal symptoms when rate of opioid infusion is disrupted or decreased

Locations

Country	Name	City	State
Thailand	Faculty of Pharmacy, Mahidol University	Ratchathewi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

Brown C, Albrecht R, Pettit H, McFadden T, Schermer C. Opioid and benzodiazepine withdrawal syndrome in adult burn patients. Am Surg. 2000 Apr;66(4):367-70; discussion 370-1. — View Citation

Cammarano WB, Pittet JF, Weitz S, Schlobohm RM, Marks JD. Acute withdrawal syndrome related to the administration of analgesic and sedative medications in adult intensive care unit patients. Crit Care Med. 1998 Apr;26(4):676-84. — View Citation

Korak-Leiter M, Likar R, Oher M, Trampitsch E, Ziervogel G, Levy JV, Freye EC. Withdrawal following sufentanil/propofol and sufentanil/midazolam. Sedation in surgical ICU patients: correlation with central nervous parameters and endogenous opioids. Intens — View Citation

Wang PP, Huang E, Feng X, Bray CA, Perreault MM, Rico P, Bellemare P, Murgoi P, Gélinas C, Lecavalier A, Jayaraman D, Frenette AJ, Williamson D. Opioid-associated iatrogenic withdrawal in critically ill adult patients: a multicenter prospective observatio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of opioid withdrawal symptoms	Incidence of opioid withdrawal symptoms detected by self-developed assessment tool or the Diagnostic and Statistical Manual 5th edition (DSM-V)	0, 1, 3, 6, 24 and 72 hour after reduction or discontinuation of intravenous opioid
Secondary	Weaning days	Time from initial weaning from mechanical ventilator until extubation	28 days
Secondary	Ventilator days	Time from intubation until extubation	28 days
Secondary	ICU length of stay	Time from admission to ICU until discharge from ICU	28 days