Opioid Withdrawal Symptoms in Critically Ill Patients

NCT03374722 | Completed

• 1 other identifier: 10-60-68
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Substance Withdrawal Syndrome; Critical Illness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Weaning days

  28 days

• Ventilator days

  28 days

• ICU length of stay

  28 days

Study Arms (1)

Mechanically ventilated critically ill patients

Mechanically ventilated critically ill patients who receive opioid as continuous infusion for more than 24 hours

Drug: Opioids

Interventions

Opioids DRUG

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

Mechanically ventilated critically ill patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intensive care units

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Pharmacy, Mahidol University

Ratchathewi, Bangkok, 10400, Thailand

Location

Related Publications (5)

• Wang PP, Huang E, Feng X, Bray CA, Perreault MM, Rico P, Bellemare P, Murgoi P, Gelinas C, Lecavalier A, Jayaraman D, Frenette AJ, Williamson D. Opioid-associated iatrogenic withdrawal in critically ill adult patients: a multicenter prospective observational study. Ann Intensive Care. 2017 Sep 2;7(1):88. doi: 10.1186/s13613-017-0310-5.

  PMID: 28866754 RESULT

• 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. Intensive Care Med. 2005 Mar;31(3):380-7. doi: 10.1007/s00134-005-2579-3. Epub 2005 Feb 16.

  PMID: 15714323 RESULT

• 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.

  PMID: 10776874 RESULT

• 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. doi: 10.1097/00003246-199804000-00015.

  PMID: 9559604 RESULT

• Taesotikul S, Dilokpattanamongkol P, Tangsujaritvijit V, Suthisisang C. Incidence and clinical manifestation of iatrogenic opioid withdrawal syndrome in mechanically ventilated patients. Curr Med Res Opin. 2021 Jul;37(7):1213-1219. doi: 10.1080/03007995.2021.1928616. Epub 2021 May 25.

  PMID: 33966568 DERIVED

MeSH Terms

Conditions

Substance Withdrawal Syndrome; Critical Illness

Interventions

Analgesics, Opioid

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Study Officials

• Suthinee Taesotikul, Pharm.D.

  Faculty of Pharmacy, Mahidol university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 12, 2017
• First Posted: December 15, 2017
• Study Start: January 1, 2018
• Primary Completion: August 31, 2018
• Study Completion: October 7, 2018
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

TH (1)