---
title: Effectiveness of Intranasal Versus Intravenous Fentanyl in Preterm and Term Newborns for Pain Prevention
nct_id: NCT02125201
overall_status: COMPLETED
phase: PHASE4
sponsor: HaEmek Medical Center, Israel
study_type: INTERVENTIONAL
primary_condition: Pain
countries: Israel
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02125201.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02125201"
ct_last_update_post_date: 2018-02-06
last_seen_at: "2026-05-12T07:15:45.985Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effectiveness of Intranasal Versus Intravenous Fentanyl in Preterm and Term Newborns for Pain Prevention

**NCT ID:** [NCT02125201](https://clinicaltrials.gov/study/NCT02125201)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 21
- **Lead Sponsor:** HaEmek Medical Center, Israel
- **Conditions:** Pain
- **Start Date:** 2014-06
- **Completion Date:** 2015-03
- **CT.gov Last Update:** 2018-02-06

## Brief Summary

Neonatal intensive care unit patients undergoes many painful procedures during their hospitalization. Effective pain control in such procedures as intubation, catheterization, central line insertion, chest tube insertion, etc. is an important part of treatment. Opioids administration is a common practice for acute pain prevention. Fentanyl is the preferred opioid due to it rapid onset and short duration of action.

Fentanyl may be given intravenously, transcutaneous transmucosal and intranasal. Intranasal administration is practiced for about 20 years. A rich vascular supply in a nose provides rapid absorption of the drug. This uninvasive root is now popular for pain prevention and treatment. There are about 20 trials with intranasal fentanyl administration to children from 6 month old to 18 years. The investigators did not find information about this way of administration in neonates.

In our pilot study the investigators want to check if intranasal administration of fentanyl is safe and effective in pain prevention in term and preterm neonates during invasive procedures and to compare it with intravenous route of administration.

## Eligibility

- **Maximum age:** 3 Months
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

Term and preterm neonates that require invasive procedures (elective or semielective intubation, central line insertion , chest drain or abdominal drain)

Exclusion Criteria:

1. Neonates with prolonged analgesic treatment before the procedure
2. Neonates with neurologic problem which can interact with pain assessment
```

## Arms

- **intranasal fentanyl** (EXPERIMENTAL) — Intranasal Fentanyl 1.5-2 mcg/kg
- **intravenous fentanyl** (ACTIVE_COMPARATOR) — Intravenous Fentanyl 1-1.5 mcg/kg

## Interventions

- **Fentanyl** (DRUG) — A neonate will recieve Fentanyl intranasal or intravenous 5 minutes before the procedure The nurse will check his pain scale If the pain scale will be more than 4 the neonate will recieve the second dose of Fentanyl

## Primary Outcomes

- **Pain scale - N-PASS** _(time frame: before the intervention and till one our after intervention)_

## Locations (1)

- NICU, Afula, Israel

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.nicu|afula||israel` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02125201.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02125201*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*