NCT04651556

Brief Summary

The investigators are going to study the analgesic efficacy of intraperitoneal instillation of a combination of Magnesium sulphate with bupivacaine versus ordinary used parenteral analgesics for pain relief after laparoscopic surgeries in pediatrics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2020

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2020

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 3, 2020

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

1.2 years

First QC Date

November 12, 2020

Last Update Submit

December 6, 2020

Conditions

Intraperitoneal Magnesium Sulphate in Laparoscope in Pediatrics

Keywords

intraperitoneal, laparoscopic surgeries, pediatrics

Outcome Measures

Primary Outcomes (5)

  • FLACC score

    (Face, Leg, Activity, Cry, and Consolability) pain assessment score The scale is scored in a range of 0-10 with 0 representing no pain. assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain.

    0 minutes (immediately) postoperative

  • FLACC score

    (Face, Leg, Activity, Cry, and Consolability) pain assessment score The scale is scored in a range of 0-10 with 0 representing no pain. assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain.

    1 hour postoperative

  • FLACC score

    (Face, Leg, Activity, Cry, and Consolability) pain assessment score The scale is scored in a range of 0-10 with 0 representing no pain. assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain.

    6 hours postoperative

  • FLACC score

    (Face, Leg, Activity, Cry, and Consolability) pain assessment score The scale is scored in a range of 0-10 with 0 representing no pain. assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain.

    12 hours postoperative

  • FLACC score

    (Face, Leg, Activity, Cry, and Consolability) pain assessment score The scale is scored in a range of 0-10 with 0 representing no pain. assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain.

    24 hours postoperative

Secondary Outcomes (5)

  • Vital signs

    preoperative, postoperative (0,1,3,6,12,24 hours)

  • Vital signs

    preoperative, postoperative (0,1,3,6,12,24 hours)

  • Vital signs

    preoperative, postoperative (0,1,3,6,12,24 hours)

  • Time to first analgesic administration

    24 hours postoperative

  • Total analgesic requirements

    24 hours postoperative

Study Arms (2)

Parenteral Analgesia

ACTIVE COMPARATOR

receive ordinary analgesics via intravenous route as paracetamol (7.5- 10 mg/kg) and ketorolac (0.5 mg/kg).

Drug: paracetamol & ketorolac

Intraperitoneal instillation

ACTIVE COMPARATOR

receive (Magnesium sulphate 40 mg/kg and bupivacaine 4mg/kg) in 30 ml of isotonic 0.9%N.S intra peritoneal at the end of surgery.

Drug: Magnesium Sulfate & bupivacaine

Interventions

Magnesium Sulfate & bupivacaineDRUG

intraperitoneal instillation of a combination of Magnesium sulphate with bupivacaine

Intraperitoneal instillation
paracetamol & ketorolacDRUG

parenteral analgesics

Parenteral Analgesia

Eligibility Criteria

Age1 Year - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • ASA physical status I-II.
  • Both genders are eligible for study.
  • Patients age from 1 year to 12 years.
  • Patients undergoing laparoscopic surgeries.

You may not qualify if:

  • ASA III, IV and V class patients. 2- Presence of psychiatric disease. 3- Those with an allergy to any of the study drugs will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia university

Menoufia, Menoufia, Egypt

Location

MeSH Terms

Interventions

Magnesium SulfateBupivacaineAcetaminophenKetorolac

Intervention Hierarchy (Ancestors)

Magnesium CompoundsInorganic ChemicalsSulfatesSulfuric AcidsSulfur AcidsSulfur CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAcetanilidesIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

November 12, 2020

First Posted

December 3, 2020

Study Start

April 4, 2019

Primary Completion

June 15, 2020

Study Completion

November 15, 2020

Last Updated

December 8, 2020

Record last verified: 2020-12

Locations

EG(1)