Randomized double-blind controlled trial to assess the efficacy of intravenous acetaminophen associated with strong opioids in the treatment of acute pain in adult cancer patients: study protocol

Table 2 Study plan — schedule of enrolment, interventions, and assessment

	Study period
	Enrolment	Allocation	Post-allocation	Close out
	-12h to 0	0	24h	48h
Enrolment
Eligibility screen	X
Informed consent	X
Standard analgesic procedure	X	X	X	X
Allocation		X
Interventions
Acetaminophen 1g/100ml Q6H IV		X	X	X
Saline 100ml Q6H IV		X	X	X
Assessments
Demographic data	X
MDAS	X		X	X
Type and location of pain	X
VNRS	X		X	X
VAS	X		X	X
MEDD	X		X	X
Drug use in the past 24 h (corticosteroids, NSAIDs)	X		X	X
Cancer treatments received	X
Karnofsky score	X
CAGE-AID	X
ESAS-SF	X			X
HADS	X			X
EORTC QLQ-C15-PAL	X
Comorbidities	X
Side effects	X		X	X
Patient perception of pain improvement			X	X
MCID			X	X

MDAS Memorial Delirium Assessment Scale, VNRS Verbal Numeric Analog Scale, VAS Visual Analog Scale, MEDD Morphine Equivalent Daily Dose, CAGE-AID CAGE Adapted to Include Drugs, ESAS-SF Edmonton Symptom Assessment Scale – Spiritual Distress, Financial Burden [26, 27], HADS Hospital Anxiety and Depression Scale [25], EORTC QLQ-C15-PAL [28] European Organization for Research and Treatment of Cancer QLQ-C30, MCID minimally clinical important difference

ISSN: 1745-6215