Clinical trial NCT03374722: Opioid Withdrawal Symptoms in Critically Ill Patients
Official title: Opioid Withdrawal Symptoms in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Substance Withdrawal Syndrome
Critical Illness
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intensive care units

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of opioid withdrawal symptoms
timeFrame: 0, 1, 3, 6, 24 and 72 hour after reduction or discontinuation of intravenous opioid
Secondary outcomes:
measure: Weaning days
timeFrame: 28 days
measure: Ventilator days
timeFrame: 28 days
measure: ICU length of stay
timeFrame: 28 days
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Faculty of Pharmacy, Mahidol University
state: Bangkok
Study officials:
affiliation: Faculty of Pharmacy, Mahidol university
name: Suthinee Taesotikul, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. Intensive Care Med. 2005 Mar;31(3):380-7. doi: 10.1007/s00134-005-2579-3. Epub 2005 Feb 16.
citation: 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.
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. doi: 10.1097/00003246-199804000-00015.
citation: 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.