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Completed

NCT Number: NCT00405444

Intranasal Fentanyl Versus Placebo for Catheterization During a Voiding Cystourethrogram in Children

The purpose of this study is to determine whether intranasal fentanyl is better than placebo at decreasing pain in children 4-8 years of age during urinary catheterization for a VCUG study.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

Studies have shown that the voiding cystourethrogram (VCUG) can be distressful and painful for children as the child is catheterized during the procedure. Currently no sedation or analgesia is recommended for the procedure. The practice of pediatrics is constantly seeking measures to decrease pain and distress for children. The opioid fentanyl was originally synthesized in the 1950's and 60's as an alternative to morphine and meperidine. The safety and efficacy of intranasal (IN) fentanyl has been previously demonstrated in the setting of a pediatric emergency department.

We are proposing the use of IN fentanyl for analgesia prior to the catheterization for a voiding cystourethrogram (VCUG). If we prove that IN fentanyl is effective in reducing the pain while ensuring patient safety, it could become the analgesic of choice for this procedure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 4-8 years
  • Scheduled VCUG at Sick Kids
  • Understand the consent and assent form in English

Exclusion criteria

  • Previous adverse events to fentanyl or any opioid
  • History of a chronic respiratory or cardiac illness
  • Children with developmental delay
  • Children with bilateral nasal congestion.

Treatment and study plan

Fentanyl

Drug

The dose of fentanyl that each child will receive will be 2 mcg/kg based on the child's weight. The medication will be administered 10 minutes prior to the procedure and will be dropped into the unoccluded nares over 1-2 seconds.

Sterile water

Drug

The dose of sterile water that each child will receive will be 2 mcg/kg based on the child's weight. It will be administered 10 minutes prior to the procedure and will be dropped into the unoccluded nares over 1-2 seconds.

Primary outcomes

  1. Change in pain before and after catheterization for the VCUG.

    Time frame: Will be measured up until 30 mins after the VCUG procedure.

Secondary outcomes

  1. Heart rate, respiratory rate and oxygen saturation just prior to and after the administration of fentanyl.

    Time frame: Every 5 minutes until 30 minutes after the VCUG procedure.

  2. Nausea, vomiting, itching, nasal pain/irritation or any other side effects.

    Time frame: Will be measured up until 30 mins after the VCUG procedure.

  3. Length of stay in diagnostic suite

    Time frame: Time frame determined by outcome

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Nov 30, 2006
Registry last updated
Dec 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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