Routine Use of Analgesia for Venipuncture in a Tertiary Level Neonatal Intensive Care Setting: A Quality Improvement Study Open Access

Knowledge of pain in neonates has evolved considerably from earlier beliefs that the neonatal brain is immature and cannot feel pain. A landmark study by Anand and Hickey et al. [1] in 1987 showed that neonates could feel pain, and excessive, prolonged, painful events can lead to adverse physiological effects, causing long-term adverse effects and altered perception of pain in the later years of life. A study in a tertiary level neonatal intensive care unit (NICU) reported a median of 75 painful procedures, 79.2% of which were performed without any specific analgesia during the hospital stay [2]. Another centre reported an average of eight painful procedures per day, with pain-relieving measures utilized in only 46.4% of the cases [3]. As neonates cannot verbalize their pain, they depend on caregivers to recognize, assess, and manage it. Pain management is mainly performed by non-pharmacological methods, such as skin-to-skin contact, swaddling, and breastfeeding, and pharmacological methods, such as 24% sucrose, paracetamol, and fentanyl. Studies have shown a reduction in pain scores using 24% sucrose, expressed breast milk, and skin-to-skin contact during the procedure [4, 5].

Despite the understanding of neonatal pain perception, the development of neonatal pain scales, and the availability of therapeutic measures for analgesia, routine use of pain-relieving measures in neonatal care remains substantially suboptimal. Important barriers include the persistence of the knowledge gap regarding neonatal pain and the inadequate application of the available measures to provide adequate relief [6, 7]. The upcoming quality improvement (QI) methodology is unique in its ability to bring a multidisciplinary team together, allow systematic evaluation of problems, and develop a change in practices at the frontline staff level, ultimately enhancing the success of any intervention. Anne et al. [8] in their QI model showed an increase in the use of analgesia from 13% baseline to 73% over a period of 6 months by conducting four Plan-Do-Study-Action (PDSA) cycles using teaching sessions, bedside visual aids, simulation sessions demonstrating the use of non-pharmacological measures for analgesia and video feedback-based sessions. A similar initiative by Thacker et al. [9] in 2022 showed an improvement in the use of pain control measures from a baseline of 3 to 4% to a target of 80% of procedures over 5 months, using educational sessions, visual reminders, easy accessibility to sucrose, and clustering of blood glucose monitoring with skin-to-skin contact or breastfeeding.

In our NICU, despite the availability of evidence and guidelines for monitoring and treating procedural pain in neonates, there has been poor implementation in practice. Therefore, we planned a QI initiative to address this gap. Venipuncture is the method for blood sampling in our unit. Since venipuncture or cannula insertion is one of the most common painful procedures in the NICU, we chose to target this procedure by using feasible pain control interventions. We aimed to improve the routine use of analgesia during venipuncture in neonates admitted to a level IIIb NICU from baseline to 50% by 8 weeks.

Our QI project was conducted at a university teaching hospital in Western India. It is a 42-bed NICU providing level II and III care, with approximately 1,700–1,800 admissions per year and 100% bed occupancy. To implement changes, a multidisciplinary QI team was formed, consisting of three neonatologists, two neonatology residents, and two neonatal nurses. Three phases were planned for the QI study: baseline, intervention, and sustenance.

Residents and nurses primarily engaged in venipuncture were observed while performing the procedure. We recorded the type of procedure, personnel involved, time, and analgesia used before the procedure. Anonymity was maintained throughout, and no questions were asked during the observation. Three observers who were part of the QI team observed the procedure at random times of the day to decrease bias. We conducted a baseline cross-sectional analysis of 30 procedures and found that analgesia was used in 0%. The team conducted multiple focused group discussions to analyse the problem and identify the main barriers that lead to a lack of routine analgesia during venipuncture and developed a fishbone diagram (Fig. 1) to guide the interventions. Following this, using the five-why analysis, the root cause of each problem was identified, and the important contributors were highlighted by Pareto’s principle, as shown in Table 1. Changes in ideas were adopted, adapted, or abandoned after the PDSA cycles. The sustainability of the interventions was studied for 5 months after the implementation phase.

Four PDSA cycles were planned based on fishbone analysis, Pareto, and five-why principles of 2 weeks each.

Venipuncture was carried out mainly by the residents and occasionally by nurses in our NICU, and awareness about the importance of providing analgesia was identified as a crucial step. Hence, we conducted training sessions for doctors and nurses during the first cycle. The training sessions were conducted in groups of 6–7 by the QI team members using PowerPoint presentations, which provided information about the importance and methods of providing analgesia to newborns. We allowed the groups to be heterogeneous, consisting of residents and nurses, to enhance the learning environment by sharing knowledge and experiences in different roles. Training sessions were planned over 2 weeks. The outcome measures were the frequency of analgesia use during venipuncture and the number of trained doctors or nurses.

One of the barriers to providing analgesia was the lack of accessibility of mother’s own milk (MOM) while performing the procedure. We identified that most sampling in our NICU was done between 6–8 am and 6–8 pm. Hence, mothers of the neonates who had planned blood collection at the above-mentioned hours were counselled by the residents or nurses to keep aside around 5 mL of MOM from the total milk expressed to feed their baby in a separate small closed container bedside exclusively for analgesia during the 5 am and 5 pm feeds. This aligns with our unit policy of promoting family-centred care. We use labelled containers for each infant, which helped avoid cross-contamination of milk. The milk was given orally with a 2 mL syringe and used within 4 h of expression. The outcome measure was the frequency of MOM use for analgesia and the process indicator availability of bedside MOM at the time of venipuncture.

In the initial 1–2 days after delivery, due to the small volume of colostrum, MOM is usually unavailable for the use of analgesia for certain babies. We decided to keep a small amount of pasteurized donor human milk (PDHM) (15–20 mL) in a separately labelled small closed container in each section of our NICU exclusively for analgesia. PDHM in our institute comes from our own milk bank. It follows the Human Milk Bank Association of North America (HMBANA) guidelines, including screening of donors and milk pasteurization processes. To avoid cross-contamination of PDHM, It was carried out twice daily during PDHM disbursement, and unused milk was subsequently used for feeding. PDHM from the same container was used for babies, ensuring unit protocol for aseptic precautions. The unused milk was not added to the DBM pool. However, if there was leftover milk from the container set aside for analgesia, it was used for feeding within the next 4 h from the same container. The outcome measure was the frequency of PDHM use for analgesia, and the process indicator was the availability of PDHM at the time of venipuncture.

In the rare event of PDHM/MOM being unavailable, we decided to use 25% dextrose as an alternative. Each section in our NICU has a separate trolley for performing bedside procedures, which is prepared daily by a staff nurse on which 25% dextrose was made available. Healthcare workers were instructed to use this method of analgesia as the last resort. The outcome measure was the frequency of 25% dextrose use for analgesia, and the process indicator was the availability of 25% dextrose on the collection trolley at the time of venipuncture.

Observations continued in this phase, lasting 5 months. Two independent observers collected data every 4 weeks.

The data were tabulated in MS Excel and analysed using run charts.

250 observations were made during the study period of 11 months. Of these, 30 were made during baseline data collection, 30 were made after the completion of each PDSA cycle, and 100 were made during the sustenance period of 5 months.

In the first PDSA cycle, 11 residents and 27 staff nurses were trained. Due to the recruitment of new staff nurses and the hectic duty hours of the residents, the cycle was extended for 3 weeks to incorporate the maximum number of residents and nurses in the cycle. We found a 26% increase in the use of analgesia from baseline at the end of the first PDSA cycle, and the most common method of analgesia was MOM (80%) (Fig. 2, 3). Since there was a significant increase from the baseline, this intervention was adopted in our routine practice.

During the second PDSA cycle, we found a significant increase of 46% from baseline in the use of analgesia after making MOM available bedside for analgesic use. During this period, we noted that despite other options, the predominant method of providing analgesia was MOM (85%) (Fig. 3). After the third PDSA cycle, PDHM availability resulted in a marginal increase of 50% from the previous cycle (46%). Hence, this intervention did not substantially increase the use of analgesia and was abandoned. In the fourth PDSA cycle, 25% dextrose was introduced as an alternative to analgesia. However, we noted that this intervention also led to a minimal increase to 53% from the previous cycle (50%) (Fig. 2).

In the sustenance phase, we collected data every 4 weeks to ensure the continuation of analgesia. Unfortunately, we noted a drop in analgesia use to 25% in the first 2 months. This was again attributed to the frequent change in the postings of staff nurses and the shortage of junior residents in the NICU who helped with venipuncture and joined the new batch of senior residents. To address this, the team met and discussed the challenges faced. Training sessions were intensified, and additional help from the faculty and senior staff nurses was provided to ensure the implementation. In the month following the above measures, we noted an increase of 55%, which was higher than that achieved at the end of the fourth PDSA cycle. Hence, we continued the same interventions, which were part of the PDSA cycles, and periodically collected data every 4 weeks. Posters were used as visual reminders in the NICU to emphasize the continued use of analgesia. In the subsequent 2 months of the sustenance phase, we found that the rate of analgesia continued to be 60% (Fig. 2).

In our QI project, we attempted to bridge the knowledge-practice gap by identifying obstacles, planning appropriate solutions, and methodically implementing them. We realized no single intervention could lead to consistent results; it was possible only when further implementations were carried out, and earlier ones were reinforced. Although various international bodies have formulated guidelines for managing neonatal pain, few studies have examined how to implement them. A systematic review reported infrequent utilization of neonatal pain management strategies [4]. Studies have shown an improved perception and understanding of healthcare staff after an educational intervention; however, an improved understanding is not always reflected in practice [3, 4]. Thus, to bridge the gap between research findings and clinical practice, QI tools are a powerful intervention, as done in our study.

The baseline use of analgesics was dishearteningly low in our unit. Though ideally, every baby in the NICU should benefit from analgesia, we chose our target of 50% as a feasible and attainable target for the quality initiative. The EPIPAIN study published in 2008 found that only 21% of painful procedures were performed with specific analgesia [2]. An Australian survey showed that 53% of nurses used sucrose, and 78% used breast milk as an analgesic [10]. Various other studies have reported using pharmacologic analgesia to be approximately 30–40% [11, 12]. We decided to create awareness among nurses and residents by holding brief sessions in small groups. Based on the available literature, nurses and doctors often underestimate neonatal pain and use fewer pharmacological and non-pharmacological pain relief measures [13]. With this intervention, we increased analgesic use to 26%, which was a good beginning of our project.

MOM is an effective analgesic due to its sweet taste, odour and the presence of high level of tryptophan, which potentiates release of endogenous opioids and beta endorphins [14]. A recent meta-analysis by Wade et al. [15] recommended breastfeeding as the first-line intervention. However, they also added that whenever breastfeeding is impossible, 1–2 mL of MOM should be used as first-line, followed by 1–2 mL of oral 24% sugar as a second-line analgesic. Contrary to this observation, an earlier review by Benoit et al. [16] questioned the effectiveness of EBM alone as an effective pain control intervention. Shah et al. [17], in their Cochrane review, observed that MOM was more effective than no intervention or placebo but was inferior compared to direct breastfeeding and sweet solutions. However, there is no consensus regarding the amount of MOM required to relieve pain. We used 2 mL of MOM for analgesia. In our second PDSA cycle with bedside availability of MOM, we were able to achieve a 46% increase in the use of analgesia. However, keeping PDHM aside solely for analgesic use in the third PDSA did not significantly improve our goal. This was probably because the availability of MOM was not a limitation, but its use by healthcare staff was the underlying factor. Hence, we decided not to adopt this intervention in our routine practice. However, the option of using disbursed PDHM for feeding would continue to be available for analgesic use as a part of unit protocol. In the fourth PDSA cycle, we observed a marginal increase in bedside availability of 25% dextrose. This reiterates that, as MOM/PDHM was readily available and accessible bedside owing to the previous PDSA cycles, increasing accessibility of 25% dextrose had minimal impact on the analgesic use. This implies that the availability of analgesia was not an issue, but its use by healthcare providers was the under-factor.

Overall, through this QI project, we demonstrated a significant increase in analgesia use, similar to other QI initiatives, which improved their use of analgesia by up to 90% with QI initiatives [18]. QI models have been globally used to drive similar changes in analgesia use in NICUs. The “I feel good” project, a collaborative in Canada, increased overall procedural analgesia from 10 to 25% [19]. Similarly, a QI from Japan involving 12 sites showed increased use of analgesia, from 18% to a maximum of 85% over a year [20].

Our QI project focused on an area that required significant improvement in our unit to improve neonatal care. The interventions designed were simple and feasible for integration into routine practice. We concentrated on non-pharmacological measures, promoting mothers’ milk, incorporating parental involvement in QI, and fostering family-centred care within the unit. Our findings can be reflected in any institute where personnel rotation is a significant issue in maintaining care, which can be addressed by continued education to maintain sustainability.

Our study is limited to resource-limited, high-burden NICUs with similar unit policies, infrastructure, healthcare staff, and nurse-to-patient ratios. Pain scores such as PIPP-R are used for routine pain monitoring during procedures in our unit, however, as the interventions for analgesia used in our study are evidence-based and have established a reduction in pain scores, we did not collect data on the pain scores recorded by the bedside team for study purposes, which remains a limitation of our study.

The interventions in our QI study led to significant improvements in the use of analgesia during venipuncture in the NICU. Regular training sessions for healthcare workers, visual reminders, and easy accessibility of analgesic measures at the bedside are simple measures that should be incorporated into routine practice to improve analgesia during venipuncture.

The authors wish to thank Dr. Sangeeta Ravat, Dean of Seth GS Medical College, and KEM Hospital, Mumbai, for granting permission for publication.

The study was conducted after receiving ethical permission from the Institutional Ethics Committee at Seth GS Medical College and Kind Edward Memorial Hospital, Mumbai, India (EC-OA-26/2020). The ethics board exempted the study from written informed consent from participants (clinicians who were observed) as it was a quality initiative project.

The authors have no conflicts of interest relevant to this article to disclose.

No external funding was received for this study.

R.N., A.H., and D.M.: conception and design of the study; So.S., Sa.S., and M.G.: data collection; So.S., D.M., and M.G.: data interpretation. All authors contributed to the critical review of data analysis, article writing, drafting/revising the article, approving the final version, and accepting accountability for all aspects of the work.

All data generated or analysed during this study are included in this article. Further enquiries can be directed to the corresponding author.