Comparing Intranasal Midazolam, Oral Melatonin, and Distraction Cards for Pain and Stress Management in Pediatric Intravenous Line Insertion: A Randomized Controlled Trial

Background Intravenous (IV) line insertion causes pain and stress in children. However, we know about the permanent effects of painful experiences on a child’s life, but this main clinical complaint has been underestimated and left untreated. This study was conducted to compare the effect of the nonpharmacological method of “distraction” and two medicinal methods, “nasal midazolam” and “oral melatonin,” on reducing pain and stress caused by IV line insertion in children. Methods Patients were randomly assigned to one of the four groups: control, distraction, oral melatonin, and nasal midazolam. Pain and stress scores were measured and compared using a standard questionnaire during and after IV insertion. Results In this study, the partial η 2 = 0.12 for stress and 0.085 for pain. Parental presence showed a stronger effect ( p value < 0.05), with a partial η 2 = 0.27 in reducing stress and 0.30 in reducing pain. The underlying disease of the child had no significant relationship with pain and anxiety ( p value > 0.05). Conclusion In this study, we found that the levels of stress and pain were statistically significant between the 4 study groups: the children who had not managed to reduce pain and anxiety before IV insertion (control group), the oral melatonin group, the nasal midazolam group, and the distraction group ( p value = 0.016 and p value = 0.002, respectively). Oral melatonin is more effective than nasal midazolam in reducing pain and stress caused by venipuncture in children. Trial Registration Iranian Registry of Clinical Trials (IRCT): 20220128053852N2