Table 3.

PACC 2016 safety recommendations for IT opioid therapy [39]

Statement	USPSTF Evidence Level*	USPSTF Recommendation Grade†	PACC Consensus Strength‡
IT opioid delivery is a relatively safe and effective method for chronic infusion to treat cancer-related and non–cancer-related pain	II-2	A	Strong
Respiratory depression can occur with IT opioid administration, and careful dosing is critical to avoid this complication	II-3	B	Strong
Concurrent use of sedative medications in patients receiving opioids should be minimized or avoided	II-2	A	Strong
Single-shot trialing with IT opioids is a safe strategy, with an observation period of ≥6 hours in an outpatient or inpatient site of service; outpatients should have continued observation after discharge with a responsible adult	II-3	B	Moderate
Endocrinopathic side effects are a consequence of IT opioids, and preoperative surveillance and monitoring are recommended	II-3	A	Strong
Lower extremity edema can occur by an unknown mechanism and can be mitigated by transition to a more lipophilic opioid	III	C	Strong
Urinary retention is a complication that may be mitigated by the administration of parasympathomimetic medications	III	C	Moderate
Nausea, vomiting, and pruritus are consequences of IT delivery of opioids and, although they typically resolve with time, should be considered when employing opioids for chronic infusion	III	C	Moderate
Consideration of patient candidacy for IT opioid therapy is crucial, and evaluation should consider the pain generator(s), patient age, location and type of pain, previous opioid exposure, and patient comorbidities	II-2	B	Strong

Adapted from: Deer TR, Pope JE, Hayek S, et al. The Polyanalgesic Consensus Conference (PACC): Recommendations on intrathecal drug infusion systems best practices and guidelines. Neuromodulation 2017;20(2):96–132 [9]; and Deer TR, Pope JE, Hayek S, et al. The Polyanalgesic Consensus Conference (PACC): Recommendations for intrathecal drug delivery: Guidance for improving safety and mitigating risks. Neuromodulation 2017;20(2):155–76 [39].

IT = intrathecal; PACC = Polyanalgesic Consensus Conference; USPSTF = United States Preventive Services Task Force.

^*Evidence grades: I, at least one controlled and randomized clinical trial, properly designed; II-1, well-designed, controlled, nonrandomized clinical trials; II-2, cohort or case studies and well-designed controls, preferably multicenter; II-3, multiple series compared over time, with or without intervention and surprising results in noncontrolled experiences; III, clinical experience–based opinions, descriptive studies, clinical observations, or reports of expert committees.

^†Recommendation grades: A, extremely recommendable (good evidence that the measure is effective and benefits outweigh the harms); B, recommendable (at least moderate evidence that the measure is effective and benefits exceed harms); C, neither recommendable nor inadvisable (at least moderate evidence that the measure is effective, but benefits are similar to harms and a general recommendation cannot be justified); D, inadvisable (at least moderate evidence that the measure is ineffective or that the harms exceed the benefits); I, insufficient, low-quality or contradictory evidence (the balance between benefit and harms cannot be determined).

^‡Level of consensus among members of the PACC: strong, >80% consensus; moderate, 50% to 79% consensus; weak, <49% consensus.