A randomized controlled trial on virtual reality distraction during venous cannulation in young children.

BACKGROUND AND OBJECTIVES: Pain management in children is often inadequate, and the single most common painful procedure in children who are hospitalized is needle procedures. Virtual reality (VR) has been shown to decrease anxiety and pain in children undergoing painful procedures primarily in children from the age of 7 years. Our aim for this study is to investigate patient satisfaction and pain reduction by using a three-dimensional VR interactive game as a distraction in 4-7 years old children during venous cannulation. METHODS: In this randomized clinical trial, we enrolled 106 children aged 4-7 years who were scheduled for venous cannulation. Patients assigned to the control group were adherent to standard of care, including topical numbing cream, positioning, and distraction in this group by games of choice on a tablet/smartphone. In the study group, children were adherent to standard of care and were distracted by an interactive VR game. Primary outcomes were patient satisfaction and the procedural pain assessed by using Wong-Baker Faces Pain Rating Scale; secondary outcomes were the procedural time and any adverse events. RESULTS: We found an overall high level of patient satisfaction with our regime of topical numbing cream, positioning, and distraction. The primary outcome of pain during the procedure was median 20 mm (IQR 0-40) and 20 mm (IQR 0-55) (Wong-Baker 0-100 mm) in the VR group and the control group, respectively (difference: 0 mm, 95%CI: 0-20, p = .19). No significant difference was found in procedural times. The number of adverse effects was low, with no significant difference between the two groups. CONCLUSIONS: VR distraction is an acceptable form of distraction for children 4-7 years old when combined with topical numbing cream and positioning during preoperative venous cannulation. No difference was found between VR- and smartphone/tablet distraction.

Immersive Virtual Reality for Pediatric Procedural Pain: A Randomized Clinical Trial.

BACKGROUND AND OBJECTIVES: Pain management in children often is inadequate, and the single most common painful procedure in children who are hospitalized is needle procedures. Virtual reality (VR) is a promising and engaging intervention that may help to decrease anxiety and pain in children undergoing painful procedures. Our aim for this study is to investigate patient satisfaction and pain reduction by using a three-dimensional VR interactive game as a distraction. METHODS: In this randomized clinical trial, we enrolled 64 children aged 7 to 16 years who were scheduled for venous cannulation. Patients assigned to the control group were adherent to our standard of care, including topical numbing cream, positioning, and distraction by a specialized pain nurse. In the study group, children were adherent to the standard of care and were distracted by an interactive VR game. Primary outcomes were patient satisfaction and the procedural pain assessed by using a visual analog score; secondary outcomes were the procedural time and any adverse events. RESULTS: We found a high level of patient satisfaction with using the VR custom-made three-dimensional interactive game. All children (28 of 28 [100%]) in the VR group answered that they would prefer VR as a distraction for a later procedure, a borderline significant result compared with that of the control group (26 of 31 [84.9%]). No significant difference was found in pain scores and procedural times between the 2 groups. The number of adverse effects was low, with no significant difference between the 2 groups. CONCLUSIONS: We found no difference in pain scores but higher satisfaction when using VR versus standard care as part of a multimodal approach for management of procedural pain in children.

Procedure-related pain in children in a Danish University Hospital. A qualitative study.

BACKGROUND: Children being cared for in hospital often undergo multiple diagnostic and therapeutic procedures. Procedure-related pain, anxiety, and distress may consequently place a significant burden on the children. Although standards for pain management exist, procedure-related pain remains inadequately treated. OBJECTIVE: To determine the frequency and pain intensity of procedures in children, as well as the associated pharmacologic interventions to manage the pain in a Danish University Hospital. METHODS: During a 3-month period in 2013, a structured questionnaire was used to prospectively record all procedures performed on children from 1 month to 18 years of age. Directly after the procedure, the pharmacologic pain management interventions and the pain intensity were recorded. Pain intensity was measured by using age-appropriate pain scales. Positioning and prior experience with the procedure were recorded. RESULTS: Of the 316 children included in the study, 72% experienced none to mild pain, 8.5% experienced moderate to severe pain during the procedures, and 65% had a pharmacologic pain management intervention. Significant higher median VAS score was found during venipuncture in the children sitting on the lap of their parents compared with other positions (P < 0.05), and significant lower median VAS score was found in children who had experienced the procedure before (P < 0.05). CONCLUSION: Most children experienced mild pain during procedures. The children's positioning during the procedure and prior experience with the procedure seem to influence their experience of procedural pain and it is therefore essential that therapy is tailored for each child and includes a multimodal approach.

Intranasal sufentanil/ketamine analgesia in children.

BACKGROUND: The management of procedural pain in children ranges from physical restraint to pharmacological interventions. Pediatric formulations that permit accurate dosing, are accepted by children and a have a rapid onset of analgesia are lacking. OBJECTIVES: To investigate a pediatric formulation of intranasal sufentanil 0.5 mcg·kg(-1) and ketamine 0.5 mg·kg(-1) for procedural pain and to characterize the pharmacokinetic (PK) profile. METHODS: Fifty children (≥10 kg) scheduled for a painful procedure were included in this prospective nonrandomized open-label clinical trial. Thirteen of these children had central venous access for drug assay sampling; enabling a compartmental PK analysis using nonlinear mixed-effects models. Pain intensity before and during the procedure was measured using age-appropriate pain scales. Heart rate, oxygen saturation and sedation were recorded. RESULTS: Children had a mean age of 8.8 (sd 4.9) years and weight 35.2 (sd 20.1) kg. Sufentanil/ketamine nasal spray was effective (procedural pain intensity scores ≤5 (0-10)) in 78% of the painful procedures. The spray was well accepted by 94% of the children. Oxygen saturation and heart rate remained stable, and sedation was minimal. The bioavailability of sufentanil and ketamine was 24.6% and 35.8%, respectively. Maximum plasma concentration (Cmax) of sufentanil was 0.042 mcg·l(-1) (coefficient of variation (CV) 12.9%) at 13.8 min (CV 12.4%) (Tmax). Cmax for ketamine was 0.102 mg·l(-1) (CV 10.8%), and Tmax was 8.5 min (CV 17.3%). CONCLUSION: Sufentanil/ketamine nasal spray provided rapid onset of analgesia for a variety of painful procedures with few adverse effects and has promising features for use in pediatric procedural pain management.