Magnesium Sulfate as an Adjuvant to Caudal Bupivacaine in Lower Abdominal Surgeries in Paediatrics.

NCT03322878 | Unknown Phase 4

• 1 other identifier: N-45 -2017
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

Intravenous magnesium has been studied in pediatrics to reduce agitation after sevoflurane anesthesia in children undergoing adenotonsillectomy, reduce intraoperative rocuronium requirements, prevent laryngospasm and coughing after removal of the endotracheal tube in patients undergoing adenotonsillectomy. The aim of this study is to investigate the role of intravenous magnesium sulfate on postoperative pain management in paediatrics and to compare it with its effect when administered caudally in children undergoing lower abdominal surgeries.

Conditions

Pain, Postoperative

Keywords

postoperative pain , pediatrics , magnesium sulfate

Outcome Measures

Primary Outcomes (1)

• The analgesic effect of intravenous magnesium in children undergoing lower abdominal surgeries

  Post operative pain score will be assessed using children's Hospital of Eastern Ontario Pain scale which is based on 6 criteria: * Crying * Facial expression * Child verbal expression * Torso (body position) * Touching or grabbing at wound * Legs position Criterion 1 is given a score of 1-3, criterion 2 and 3 are given a score of 0-2 while criterion 4, 5 and 6 are given a score of 1-2; making the worst possible score 13 while the least possible score is 4. A total score ≤ than 8 indicate adequate analgesia.

  12 hours

Secondary Outcomes (2)

• Time to first rescue analgesia

  12 hours

• Post operative sedation score

  30 minutes

Study Arms (3)

Intravenous magnesium group (Group IV)

EXPERIMENTAL

Group IV (n=30) will receive intravenous (IV) 20 ml magnesium SO4 (50 mg/ kg 10% MgSO4(magnesium sulphate) diluted in normal saline to a total volume of 20 ml(milliliter) ) and caudal anaesthesia using (bupivacaine 0.25% diluted in normal saline with total volume of 1 mL/kg) .

Drug: Magnesium SO4

Caudal magnesium group (Group CA)

ACTIVE COMPARATOR

Group CA (n=30) will receive IV 20 ml normal saline and caudal anaesthesia using (bupivacaine 0.25% and 50 mg Magnesium SO4 diluted in normal saline with total volume of 1mL/kg).

Drug: Magnesium SO4

Placebo group (Group P)

PLACEBO COMPARATOR

Group P (n=30) ) will receive IV 20 ml normal saline and caudal anaesthesia using (bupivacaine 0.25% diluted in normal saline with total volume of 1 mL/kg).

Drug: Magnesium SO4

Interventions

Magnesium SO4 DRUG

The intravenous solutions (magnesium 10% for group IV or saline 0.9% for group CA and P) will be started then caudal block will be performed by the same anesthetist. Under complete aseptic conditions a caudal puncture with 5 cm short beveled 22 G caudal needle will be used in the lateral decubitus position. After identifying the space using the loss of resistance technique with saline, the study solutions will be injected slowly with repetitive intermittent aspiration.

Also known as: Caudal anaesthesia

Caudal magnesium group (Group CA); Intravenous magnesium group (Group IV); Placebo group (Group P)

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• age between 1 and 7 years, ASA(American Society of Anesthesiologists) physical status class \|- \|\| , patients scheduled for lower abdominal surgeries.

You may not qualify if:

• patients with psychiatric disorders , children with cardiovascular,respiratory ,hepatic or renal dysfunction , known contraindications to regional anesthesia, ASA class \|\|\|- \|V, hypersensitivity to magnesium or regular analgesic drugs.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Manal M El gohary

  Professor

  PRINCIPAL INVESTIGATOR

• Amina A Ela

  Assistant professor

  STUDY DIRECTOR

• Heba M Nassar

  Assistant professor

  STUDY CHAIR

Central Study Contacts

Magda S Rezk

CONTACT

+20127812221; Gloria_gloria4@hotmail.com

Magda Elsharbatly

CONTACT

+201278122220; Magdasaleh55@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer, anesthesia department,Cairo University

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: October 26, 2017
• Study Start: November 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 6, 2017

Record last verified: 2017-11