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Completed

NCT Number: NCT05324891

Dexmedetomidine Versus Fentanyl for Sedation of Postoperative Mechanically Ventilated Neonates

Newborn infants experience pain after surgical procedures,prevention and management of pain in neonates is important due to its deleterious consequences. Fentanyl is a widely used analgesic which promotes rapid analgesia,however, is not free of adverse effects including chest wall rigidity, hypothermia, hypotension, respiratory depression and tolerance.Dexmedetomidine is a selective α 2-adrenergic agonist can cause sedation, anxiolysis, analgesia and minimal respiratory depression.Therefore, the objective of the study is to evaluate the safety and efficacy of dexmedetomidine compared to fentanyl in postoperative mechanically ventilated neonates.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

1 hour–4 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

A prospective, randomized trial, which was conducted upon neonates who needed postoperative mechanical ventilation in Neonatal Intensive Care Unit, Mansoura University Children's Hospital.The patients were randomized to two groups according to the drug they received for postoperative sedation. The first group received dexmedetomidine infusion and the second group received fentanyl infusion.Our primary outcome was the efficacy of postoperative sedation score, and the secondary outcomes were plasma cortisol level, time to extubation, time to reach 100ml/kg enteral feed, need for adjuvant sedative and skeletal muscle relaxant, length of the hospital stay, side effects of sedative drugs and mortality.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Neonates need postoperative ventilation.

Exclusion criteria

  • Major congenital cardiovascular anomalies.
  • Chromosomal anomalies.
  • Grade IV intraventricular hemorrhage.
  • Tracheoesophageal fistula with wide gap (distance between proximal and distal end more than two centimeters).

Treatment and study plan

Dexmedetomidine

Drug

Infants received dexmedetomidine IV loading dose: 0.5 mcg/kg given over 20 minutes followed by maintenance dose 0.3 µg/kg/hour by infusion over 24 hours.Weaning was done when the patient was about to be extubated or with maximum 5 days after the randomization.

Fentanyl

Drug

Infants received Fentanyl IV continuous infusion: 1µg/ kg /hour. Weaning was done when the patient was about to be extubated or with maximum 5 days after the randomization.

Primary outcomes

  1. The efficacy of postoperative sedation according to pain score.

    Time frame: upto five days after surgical intervention

    Assessment of Neonatal Pain, Agitation and Sedation Scale immediately after the operations then every 12 hours till 5 days

Secondary outcomes

  1. Plasma cortisol level

    Time frame: Within 48 hours after surgical intervention

    Plasma as a base line after the operation and another two measures one after 24 hours from the operation and the other after 48 hours

  2. Need of adjuvant analgesics or sedatives

    Time frame: upto five days after surgical intervention

    Infants in both groups received open-label intravenous fentanyl boluses at a dose of 1µg/kg, as adjuvant analgesic when the pain score was more than 3 points. The dose was repeated, based on pain score assessment, at a minimum interval of 2-4 hours. Also, both groups received midazolam bolus at a dose of 0.1 mg/ kg/dose IV as adjuvant sedative in both groups when the patient was agitated.

  3. Need of skeletal muscle relaxant

    Time frame: upto five days after surgical intervention

    Neonates in both groups received Pancuronium at a dose of 0.1 mg/ kg /dose IV as a skeletal muscle relaxant when two boluses of midazolam failed to control agitation

  4. Time to extubation.

    Time frame: upto 21 days postoperative

    Days upon mechanical ventilation

  5. Time to reach 100ml/kg/day enteral feed.

    Time frame: upto 21 days postoperative

    Days to reach 100ml/kg/day enteral feed.

  6. Length of hospital stay.

    Time frame: upto 30 days postoperative

    Days of hospital admission

  7. Mortality

    Time frame: upto 21 days postoperative

    Death

  8. Adverse effects of the sedative drugs

    Time frame: upto seven days after surgical intervention

    Hypotension, bradycardia, chest wall rigidity, feeding intolerance withdrawal signs,re-intubation within 48 hours

  9. Culture-proven sepsis

    Time frame: upto 30 days after surgical intervention

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 13, 2022
Registry last updated
Apr 13, 2022

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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