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NCT Number: NCT06793267

Ultrasound Assessment of Metoclopramide's Effect on Stomach Volume in Urgent Pediatric Trauma Surgery

assess the efficacy of metoclopramide in reducing the gastric contents and volume in pediatric trauma prepared for urgent surgical interventions.

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Key information

Conditions

Age range

0 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

Gastric volume is a critical consideration in pediatric patients undergoing urgent surgical procedures, particularly in trauma cases where rapid sequence induction is required to minimize the risk of aspiration. Point-of-care gastric ultrasonography (gastric PocUs) allows evaluation of the volume and type of stomach contents. Previous studies have reported that gastric contents and volume measured using gastric PoCUS are significantly correlated with cross-sectional antral area. as a result, bedside gastric PocUs is considered a reliable and reproducible technique. gastric PocUs scan can distinguish an empty stomach from a full stomach based on qualitative results by distinguishing the physical properties of gastric fluid. The presence of thick fluid and solid contents indicate a full stomach.in contrast, the presence of clear gastric fluid is normal in healthy, fasted individuals at low risk of aspiration. as a result, assessing the volume of clear fluid in the stomach may have utility in identifying high stomach volumes that are incompatible with the fasting state.

Metoclopramide is a prokinetic chlorobenzamide derivative that accelerates gastric emptying and reduces gastric volume. Metoclopramide can be safely used preoperatively prior to cesarean section (cs). Metoclopramide has been extensively studied as a premedication for abdominal surgery, particularly in obstetric populations. Due to favorable effect of reducing gastric fluid volume, metoclopramide is commonly used to reduce the risk of aspiration pneumonia during surgery. Metoclopramide reportedly has synergistic dual activity in parturient women; an antiemetic effect on the chemoreceptor trigger zone and peripheral activity in increasing the tone of the lower esophageal sphincter and decreasing the time required for gastric emptying. the mortality of aspiration pneumonia-related is reportedly as high as 5%, with aspiration pneumonia responsible for up to 9% of all anesthesia-related deaths. Metoclopramide is well known for its ability to enhance gastric emptying however, to the best of our knowledge, the effectiveness of metoclopramide in enhancing gastric emptying has yet to be evaluated with ultrasonography in preoperative settings, particularly in urgent pediatric trauma.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Paediatric urgent trauma

Exclusion criteria

  • Guardian' refusal.
  • Presence of head trauma.

Treatment and study plan

Metoclopramide (Maxolon)

Drug

Participants will receive 0.15 mg/kg of metoclopramide administered intravenously. The drug will be diluted in 2 ml of solution prior to administration.

Saline

Drug

patients will recive normal saline 0.9% 2ml intravenous

Primary outcomes

  1. ultrasonographic assessment of the effect of metoclopramide on morphology of the gastric antrum

    Time frame: baseline

    Ultrasonographic evaluation was performed to study the impact of metoclopramide on the morphology of the gastric antrum. The cross-sectional area (CSA) of the antrum was calculated using the Bolondi et al. method with the formula:Antral CSA = π (AP × CC) / 4

Secondary outcomes

  1. effect of metoclopramide on gastric grading was assessed using a three-point grading systems

    Time frame: baseline

    The effect of metoclopramide on gastric grading was evaluated using a three-point grading system as follows:

    G-0: The antrum is flat and empty in both supine and right lateral positions (RLP).

    G-1: The antrum contains fluid in the right lateral position but is empty in the supine position.

    G-2: The antrum contains fluid in both supine and right lateral positions.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Ultrasonoraphic Asessment of Metoclopramide Effect on Gastric Volume in Urgent Surgical Trauma Pediateric Patients. Randomozed Controlled Double Blind Study.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 27, 2025
Registry last updated
Jan 27, 2025

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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