Dataset Information

A Pilot Randomized Controlled Trial of Outcomes Associated with Parent-Nurse Controlled Analgesia vs. Continuous Opioid Infusion in the Neonatal Intensive Care Unit.

ABSTRACT:

Purpose

Prospectively compare parent/nurse controlled analgesia (PNCA) to continuous opioid infusion (COI) in the post-operative neonatal intensive care unit (NICU) population.

Design/methods

A randomized controlled trial compared neonates treated with morphine PNCA to those treated with morphine COI. The primary outcome was average opioid consumption up to 3 post-operative days. Secondary outcomes included 1) pain intensity, 2) adverse events that may be directly related to opioid consumption, and 3) parent and nurse satisfaction.

Results

The sample consisted of 25 post-operative neonates and young infants randomized to either morphine PNCA (n = 16) or COI (n = 9). Groups differed significantly on daily opioid consumption, with the PNCA group receiving significantly less opioid (P = .02). Groups did not differ on average pain score or frequency of adverse events (P values > .05). Parents in both groups were satisfied with their infant's pain management and parents in the PNCA group were slightly more satisfied with their level of involvement (P = .03). Groups did not differ in nursing satisfaction.

Conclusions

PNCA may be an effective alternative to COI for pain management in the NICU population. This method may also substantially reduce opioid consumption, provide more individualized care, and improve parent satisfaction with their level of participation.

Clinical implications

Patients in the NICU represent one of our most vulnerable patient populations. As nurses strive to provide safe and effective pain management, results of this study suggest PNCA may allow nurses to maintain their patients' comfort while providing less opioid and potentially improving parental perception of involvement.

Study type

Treatment study.

Level of evidence

SUBMITTER: Czarnecki ML

PROVIDER: S-EPMC6980456 | biostudies-literature | 2020 Feb

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A Pilot Randomized Controlled Trial of Outcomes Associated with Parent-Nurse Controlled Analgesia vs. Continuous Opioid Infusion in the Neonatal Intensive Care Unit.

Czarnecki Michelle L ML Hainsworth Keri K Simpson Pippa M PM Arca Marjorie J MJ Uhing Michael R MR Zhang Liyun L Grippe Ann A Varadarajan Jaya J Rusy Lynn M LM Firary Mary M Weisman Steven J SJ

Pain management nursing : official journal of the American Society of Pain Management Nurses 20190904 1

<h4>Purpose</h4>Prospectively compare parent/nurse controlled analgesia (PNCA) to continuous opioid infusion (COI) in the post-operative neonatal intensive care unit (NICU) population.<h4>Design/methods</h4>A randomized controlled trial compared neonates treated with morphine PNCA to those treated with morphine COI. The primary outcome was average opioid consumption up to 3 post-operative days. Secondary outcomes included 1) pain intensity, 2) adverse events that may be directly related to opioi ...[more]

PMID: 31494028

Similar Datasets

Project description:BACKGROUND:This is an updated version of the original Cochrane review published in Issue 4, 2006. Patients may control postoperative pain by self administration of intravenous opioids using devices designed for this purpose (patient controlled analgesia or PCA). A 1992 meta-analysis by Ballantyne et al found a strong patient preference for PCA over non-patient controlled analgesia, but disclosed no differences in analgesic consumption or length of postoperative hospital stay. Although Ballantyne's meta-analysis found that PCA did have a small but statistically significant benefit upon pain intensity, a 2001 review by Walder et al did not find statistically significant differences in pain intensity or pain relief between PCA and groups treated with non-patient controlled analgesia. OBJECTIVES:To evaluate the efficacy and safety of patient controlled intravenous opioid analgesia (termed PCA in this review) versus non-patient controlled opioid analgesia of as-needed opioid analgesia for postoperative pain relief. SEARCH METHODS:We ran the search for the previous review in November 2004. For this update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL 2014, Issue 12), MEDLINE (1966 to 28 January 2015), and EMBASE (1980 to 28 January 2015) for randomized controlled trials (RCTs) in any language, and reference lists of reviews and retrieved articles. SELECTION CRITERIA:We selected RCTs that assessed pain intensity as a primary or secondary outcome. These studies compared PCA without a continuous background infusion with non-patient controlled opioid analgesic regimens. We excluded studies that explicitly stated they involved patients with chronic pain. DATA COLLECTION AND ANALYSIS:Two review authors independently extracted data, which included demographic variables, type of surgery, interventions, efficacy, and adverse events. We graded each included study for methodological quality by assessing risk of bias and employed the GRADE approach to assess the overall quality of the evidence. We performed meta-analysis of outcomes that included pain intensity assessed by a 0 to 100 visual analog scale (VAS), opioid consumption, patient satisfaction, length of stay, and adverse events. MAIN RESULTS:Forty-nine studies with 1725 participants receiving PCA and 1687 participants assigned to a control group met the inclusion criteria. The original review included 55 studies with 2023 patients receiving PCA and 1838 patients assigned to a control group. There were fewer included studies in our updated review due to the revised exclusion criteria. For the primary outcome, participants receiving PCA had lower VAS pain intensity scores versus non-patient controlled analgesia over most time intervals, e.g., scores over 0 to 24 hours were nine points lower (95% confidence interval (CI) -13 to -5, moderate quality evidence) and over 0 to 48 hours were 10 points lower (95% CI -12 to -7, low quality evidence). Among the secondary outcomes, participants were more satisfied with PCA (81% versus 61%, P value = 0.002) and consumed higher amounts of opioids than controls (0 to 24 hours, 7 mg more of intravenous morphine equivalents, 95% CI 1 mg to 13 mg). Those receiving PCA had a higher incidence of pruritus (15% versus 8%, P value = 0.01) but had a similar incidence of other adverse events. There was no difference in the length of hospital stay. AUTHORS' CONCLUSIONS:Since the last version of this review, we have found new studies providing additional information. We reanalyzed the data but the results did not substantially alter any of our previously published conclusions. This review provides moderate to low quality evidence that PCA is an efficacious alternative to non-patient controlled systemic analgesia for postoperative pain control.

Project description:BackgroundThe medical community is beginning to recognize the contribution of prescription opioids in the growing national opioid crisis. Many studies have compared the safety and efficacy of alternative analgesics to opioids, but none utilizing a completely opioid-free perioperative protocol in orthopedics.MethodsWe developed and tested an opioid-free perioperative analgesic pathway (from preoperative to postoperative period) among patients undergoing common elective orthopedic procedures. Patients will be randomized to receive either traditional opioid-including or completely opioid-free perioperative medications. This study is being conducted across multiple orthopedic subspecialties in patients undergoing the following common elective orthopedic procedures: single-level or two-level ACDF/ACDA, 1st CMC arthroplasty, Hallux Valgus/Rigidus corrections, diagnostic knee arthroscopies, total hip arthroplasty (THA), and total shoulder arthroplasty/reverse total shoulder arthroplasty (TSA/RTSA). The primary outcome measure is pain score at 24?h postoperatively. Secondary outcome measures include pain scores at additional time points, medication side effects, and several patient-reported variables such as patient satisfaction, quality of life, and functional status.DiscussionWe describe the methods for a feasibility randomized controlled trial comparing opioid-free perioperative analgesics to traditional opioid-including protocols. We present this study so that it may be replicated and incorporated into future studies at other institutions, as well as disseminated to additional orthopedic and/or non-orthopedic surgical procedures. The ultimate goal of presenting this protocol is to aid recent efforts in reducing the impact of prescription opioids on the national opioid crisis.Trial registrationThe protocol was approved by the local institutional review board and registered with clinicaltrials.gov (Identifier: NCT04176783 ) on November 25, 2019, retrospectively registered.

Dataset Information

A Pilot Randomized Controlled Trial of Outcomes Associated with Parent-Nurse Controlled Analgesia vs. Continuous Opioid Infusion in the Neonatal Intensive Care Unit.

Purpose

Design/methods

Results

Conclusions

Clinical implications

Study type

Level of evidence

Publications

A Pilot Randomized Controlled Trial of Outcomes Associated with Parent-Nurse Controlled Analgesia vs. Continuous Opioid Infusion in the Neonatal Intensive Care Unit.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets