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

NCT ID: NCT06793267

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-15

Study Completion Date

2026-03-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastric Volume

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group1

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

Group Type ACTIVE_COMPARATOR

Metoclopramide (Maxolon)

Intervention Type 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.

Group 2

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

patients will recive normal saline 0.9% 2ml intravenous

Interventions

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Metoclopramide (Maxolon)

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

Intervention Type DRUG

Saline

patients will recive normal saline 0.9% 2ml intravenous

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Paediatric urgent trauma

Exclusion Criteria

* Guardian' refusal.
* Presence of head trauma.
Minimum Eligible Age

0 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Rasha Ahmed Ali Hamed

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Doctor

Role: CONTACT

+20 1152800305

References

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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.

Reference Type BACKGROUND
PMID: 3896910 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 4689832 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 3993321 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 2986474 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24497372 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29624530 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24893784 (View on PubMed)

Other Identifiers

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USAMEGVUSTP

Identifier Type: -

Identifier Source: org_study_id

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