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

**Authors:** Sima Akhavan, Sedighe Shah Hosseini, Nilufar Amini, Minoo Saeidi

PMC · DOI: 10.1155/prm/9887917 · Pain Research & Management · 2026-02-11

## TL;DR

This study compares methods to reduce pain and stress in children during IV line insertion, finding that oral melatonin is more effective than nasal midazolam or distraction techniques.

## Contribution

The study provides empirical evidence comparing nonpharmacological and pharmacological interventions for pediatric IV insertion pain and stress.

## Key findings

- Oral melatonin was more effective than nasal midazolam in reducing pain and stress during IV insertion.
- Distraction techniques also reduced stress and pain, but less effectively than melatonin.
- Parental presence had a stronger effect on reducing stress and pain than the interventions tested.

## Abstract

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.

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.

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).

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.

Iranian Registry of Clinical Trials (IRCT): 20220128053852N2

## Linked entities

- **Chemicals:** midazolam (PubChem CID 4192), melatonin (PubChem CID 896)

## Full-text entities

- **Diseases:** Pain (MESH:D010146), anxiety (MESH:D001007)
- **Chemicals:** Melatonin (MESH:D008550), Midazolam (MESH:D008874)
- **Species:** Homo sapiens (human, species) [taxon 9606]

## Full text

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## Figures

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## References

27 references — full list in the complete paper: https://tomesphere.com/paper/PMC12894776/full.md

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Source: https://tomesphere.com/paper/PMC12894776