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

NCT06793267 | Not Yet Recruiting Phase 3

• 1 other identifier: USAMEGVUSTP
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gastric Volume

Outcome Measures

Primary Outcomes (1)

• ultrasonographic assessment of the effect of metoclopramide on morphology of the gastric antrum

  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

  baseline

Secondary Outcomes (1)

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

  baseline

Study Arms (2)

Group1

ACTIVE COMPARATOR

patients will receive 0.15mg/kg metoclopramide intravenously diluted in 2 ml.

Drug: Metoclopramide (Maxolon)

Group 2

PLACEBO COMPARATOR

Participants will receive a placebo in the form of 2 ml of normal saline administered intravenously.

Drug: Saline

Interventions

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.

Group1

Saline DRUG

patients will recive normal saline 0.9% 2ml intravenous

Group 2

Eligibility Criteria

• Age: 0 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Paediatric urgent trauma

You may not qualify if:

• Guardian' refusal.
• Presence of head trauma.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Bolondi L, Bortolotti M, Santi V, Calletti T, Gaiani S, Labo G. Measurement of gastric emptying time by real-time ultrasonography. Gastroenterology. 1985 Oct;89(4):752-9. doi: 10.1016/0016-5085(85)90569-4.

  PMID: 3896910 BACKGROUND

• Howard FA, Sharp DS. Effect of metoclopramide on gastric emptying during labour. Br Med J. 1973 Feb 24;1(5851):446-8.

  PMID: 4689832 BACKGROUND

• Adelhoj B, Petring OU, Pedersen NO, Andersen RD, Busch P, Vestergard AS. Metoclopramide given pre-operatively empties the stomach. Acta Anaesthesiol Scand. 1985 Apr;29(3):322-5. doi: 10.1111/j.1399-6576.1985.tb02208.x.

  PMID: 3993321 BACKGROUND

• simeneh endalew EN, gebremedhn eg, gebreegzi aH, gebreegzi AH, Kassahun HG, Kassa AA, et al. effectiveness of intravenous metoclopramide prophylaxis on the reduction of intraoperative and early postoperative nausea and vomiting after emergency caesarean section under spinal anaesthesia. J anesth clin res 2018;09:2.

  BACKGROUND

• O'Sullivan G, Sear JW, Bullingham RE, Carrie LE. The effect of magnesium trisilicate mixture, metoclopramide and ranitidine on gastric pH, volume and serum gastrin. Anaesthesia. 1985 Mar;40(3):246-53. doi: 10.1111/j.1365-2044.1985.tb10750.x.

  PMID: 2986474 BACKGROUND

• Paranjothy S, Griffiths JD, Broughton HK, Gyte GM, Brown HC, Thomas J. Interventions at caesarean section for reducing the risk of aspiration pneumonitis. Cochrane Database Syst Rev. 2014 Feb 5;2014(2):CD004943. doi: 10.1002/14651858.CD004943.pub4.

  PMID: 24497372 BACKGROUND

• Kruisselbrink R, Gharapetian A, Chaparro LE, Ami N, Richler D, Chan VWS, Perlas A. Diagnostic Accuracy of Point-of-Care Gastric Ultrasound. Anesth Analg. 2019 Jan;128(1):89-95. doi: 10.1213/ANE.0000000000003372.

  PMID: 29624530 BACKGROUND

• Van de Putte P, Perlas A. Ultrasound assessment of gastric content and volume. Br J Anaesth. 2014 Jul;113(1):12-22. doi: 10.1093/bja/aeu151. Epub 2014 Jun 3.

  PMID: 24893784 BACKGROUND

MeSH Terms

Interventions

Metoclopramide; Sodium Chloride

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Doctor

CONTACT

+20 1152800305; Fahd.16266304@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 27, 2025
• Study Start: February 15, 2025
• Primary Completion: February 15, 2026
• Study Completion: March 15, 2026
• Last Updated: January 27, 2025

Record last verified: 2025-01