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

Phase 3

Not yet recruiting

• Conditions: Gastric Volume
• Interventions: Drug: Metoclopramide (Maxolon); Drug: Saline

• Registration Number: NCT06793267
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27
• Study Start: 2025-02-15
• Primary Completion: 2026-02-15
• Study Completion: 2026-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Paediatric urgent trauma

Exclusion Criteria

• Guardian' refusal.
• Presence of head trauma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group1	Metoclopramide (Maxolon)	patients will receive 0.15mg/kg metoclopramide intravenously diluted in 2 ml.
Group 2	Saline	Participants will receive a placebo in the form of 2 ml of normal saline administered intravenously.

Primary Outcome Measures

Name	Time	Method
ultrasonographic assessment of the effect of metoclopramide on morphology of the gastric antrum	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 Outcome Measures

Name	Time	Method
effect of metoclopramide on gastric grading was assessed using a three-point grading systems	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.