Intraperitoneal Magnesium Sulphate in Laparoscope in PediatricsPhase 4NCT04651556
Intraperitoneal Magnesium Sulphate and Bupivacaine Versus Intravenous Analgesia in Laparoscopic Surgeries in Pediatrics
A Phase 4 study testing Magnesium Sulfate & bupivacaine and paracetamol & ketorolac in people with Intraperitoneal Magnesium Sulphate in Laparoscope in Pediatrics, run by Menoufia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraperitoneal Magnesium Sulphate in Laparoscope in Pediatrics
- What is being tested?
- Magnesium Sulfate & bupivacaine and paracetamol & ketorolac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Apr 2019to 15 Nov 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ASA physical status I-II.
- Both genders are eligible for study.
- Patients age from 1 year to 12 years.
- Patients undergoing laparoscopic surgeries.
Who cannot join
- 1- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of Intraperitoneal Instillation Of Magnesium Sulphate and Bupivacaine Versus Intravenous Analgesia In Laparoscopic Surgeries In Pediatrics
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.
Read the detailed description
Laparoscopic surgery is a modern surgical technique used for various surgeries such as cholecystectomy, appendectomy and hernia repair. There are a number of advantages of this technique including reduced pain and bleeding, shorter recovery time and hospital stay, and over all reduced healthcare costs. The type of pain after laparoscopic surgery differs considerably from that occurs after laparotomy. Usually patients experience diffuse pain in abdomen, back and shoulder. Acute pain after laparoscopic cholecystectomy has three different components: incisional pain (somatic pain), visceral pain (deep intra-abdominal pain), and shoulder pain (presumably referred visceral pain) . Postoperative nausea and vomiting is a commonly observed phenomenon after laparoscopic procedures. Its incidence increases depending on the anesthetic techniques used. Pain intensity usually peaks during the first postoperative period and usually declines over the following 2-3 days. Pain can prolong hospital stay and lead to increased morbidity.
Inadequately treated pain may lead to splinting, loss of sighing and decrease in vital capacity, and these may contribute to postoperative pulmonary morbidity. Various multimodal approaches have, therefore, been tried to ameliorate postoperative pain. These include parenteral analgesics, local infiltration with local anesthetics, epidural and intrathecal opioids and local anesthetics, interpleural and intercostals nerve blocks as well as intraperitoneal routes that in turn has been explored with local anesthetics and opioids . In order to get an instant relief, polypharmacy is commonly practiced which can be potentially harmful to the patient and can lead to re-admission. It has been appreciated that multiple glutamate receptors are expressed on peripheral nerve terminals, and these may contribute to peripheral nociceptive sensation .
Administration of magnesium sulphate via different routes has been used in anaesthetic practice for decreasing perioperative pain. Parenteral magnesium sulphate has been used for many years as an antiarrhythmic agent and for seizure prophylaxis in eclampsia and preeclampsia. It is N-methyl d-aspartate (NMDA) receptor antagonist and suppresses these receptor induced inflammation and hyper responsiveness . The antinociceptive effect of magnesium sulphate is not only useful in chronic pain, but it also determines in part, the duration and intensity of postoperative pain . These effects are due to calcium antagonism and decrease influx of calcium into the cell and antagonism of NMDA receptor. As these receptors regulate neuronal signalling and are involved in pain processing, magnesium sulphate by blocking this receptor, decreases postoperative pain as well .
- Being tested
- Magnesium Sulfate & bupivacaine, paracetamol & ketorolac
- Keywords
- intraperitoneal, laparoscopic surgeries, pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium Sulfate & bupivacaineDrug
intraperitoneal instillation of a combination of Magnesium sulphate with bupivacaine
paracetamol & ketorolacDrug
parenteral analgesics
| Study group | Role | What they receive |
|---|---|---|
| Parenteral Analgesia | Active comparator | receive ordinary analgesics via intravenous route as paracetamol (7.5- 10 mg/kg) and ketorolac (0.5 mg/kg). Receives: 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. Receives: Drug: Magnesium Sulfate & bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours postoperative
Secondary outcomes (5)
Vital signs
Heart rate
Measured: preoperative, postoperative (0,1,3,6,12,24 hours)
Vital signs
Arterial blood pressure
Measured: preoperative, postoperative (0,1,3,6,12,24 hours)
Vital signs
Arterial Oxygen saturation
Measured: preoperative, postoperative (0,1,3,6,12,24 hours)
Time to first analgesic administration
Time to first analgesic administration
Measured: 24 hours postoperative
Total analgesic requirements
Total analgesic requirements in 24 hours postoperative
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start4 Apr 2019
- Primary completion15 Jun 2020
- Study completion15 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraperitoneal Magnesium Sulphate in Laparoscope in PediatricsStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Walash, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651556
- Sponsor's protocol ID
- Intraperitoneal anesthesia
- Status last verified
- Dec 2020
- First submitted
- 12 Nov 2020
- Last updated
- 8 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of Intraperitoneal Instillation Of Magnesium Sulphate and Bupivacaine Versus Intravenous Analgesia In Laparoscopic Surgeries In Pediatrics
- ClinicalTrials.gov ID
- NCT04651556
- Acronym / sponsor ID
- Intraperitoneal anesthesia
- Keywords
- intraperitoneal, laparoscopic surgeries, pediatrics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Nov 2020 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Laparoscopic surgery is a modern surgical technique used for various surgeries such as cholecystectomy, appendectomy and hernia repair. There are a number of advantages of this technique including reduced pain and bleeding, shorter recovery time and hospital stay, and over all reduced healthcare costs. The type of pain after laparoscopic surgery differs considerably from that occurs after laparotomy. Usually patients experience diffuse pain in abdomen, back and shoulder. Acute pain after laparoscopic cholecystectomy has three different components: incisional pain (somatic pain), visceral pain (deep intra-abdominal pain), and shoulder pain (presumably referred visceral pain) . Postoperative nausea and vomiting is a commonly observed phenomenon after laparoscopic procedures. Its incidence increases depending on the anesthetic techniques used. Pain intensity usually peaks during the first postoperative period and usually declines over the following 2-3 days. Pain can prolong hospital stay and lead to increased morbidity.
Inadequately treated pain may lead to splinting, loss of sighing and decrease in vital capacity, and these may contribute to postoperative pulmonary morbidity. Various multimodal approaches have, therefore, been tried to ameliorate postoperative pain. These include parenteral analgesics, local infiltration with local anesthetics, epidural and intrathecal opioids and local anesthetics, interpleural and intercostals nerve blocks as well as intraperitoneal routes that in turn has been explored with local anesthetics and opioids . In order to get an instant relief, polypharmacy is commonly practiced which can be potentially harmful to the patient and can lead to re-admission. It has been appreciated that multiple glutamate receptors are expressed on peripheral nerve terminals, and these may contribute to peripheral nociceptive sensation .
Administration of magnesium sulphate via different routes has been used in anaesthetic practice for decreasing perioperative pain. Parenteral magnesium sulphate has been used for many years as an antiarrhythmic agent and for seizure prophylaxis in eclampsia and preeclampsia. It is N-methyl d-aspartate (NMDA) receptor antagonist and suppresses these receptor induced inflammation and hyper responsiveness . The antinociceptive effect of magnesium sulphate is not only useful in chronic pain, but it also determines in part, the duration and intensity of postoperative pain . These effects are due to calcium antagonism and decrease influx of calcium into the cell and antagonism of NMDA receptor. As these receptors regulate neuronal signalling and are involved in pain processing, magnesium sulphate by blocking this receptor, decreases postoperative pain as well .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parenteral Analgesia | Active comparator | Drug: paracetamol & ketorolacreceive ordinary analgesics via intravenous route as paracetamol (7.5- 10 mg/kg) and ketorolac (0.5 mg/kg). |
| Intraperitoneal instillation | Active comparator | Drug: Magnesium Sulfate & bupivacainereceive (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. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ASA physical status I-II.
- Both genders are eligible for study.
- Patients age from 1 year to 12 years.
- Patients undergoing laparoscopic surgeries.
Key exclusion criteria (1 listed)
- 1- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium Sulfate & bupivacaineintraperitoneal instillation of a combination of Magnesium sulphate with bupivacaine | Drug | Intraperitoneal instillation |
| paracetamol & ketorolacparenteral analgesics | Drug | Parenteral Analgesia |
Primary outcome
FLACC score
Time frame: 0 minutes (immediately) postoperative
(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.
FLACC score
Time frame: 1 hour postoperative
(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.
FLACC score
Time frame: 6 hours postoperative
(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.
FLACC score
Time frame: 12 hours postoperative
(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.
FLACC score
Time frame: 24 hours postoperative
(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.
5 secondary outcomes
Vital signs
Time frame: preoperative, postoperative (0,1,3,6,12,24 hours)
Vital signs
Time frame: preoperative, postoperative (0,1,3,6,12,24 hours)
Vital signs
Time frame: preoperative, postoperative (0,1,3,6,12,24 hours)
Time to first analgesic administration
Time frame: 24 hours postoperative
Total analgesic requirements
Time frame: 24 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium Sulfate & bupivacaine and paracetamol & ketorolac in people with Intraperitoneal Magnesium Sulphate in Laparoscope in Pediatrics, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FLACC score (time frame: 0 minutes (immediately) postoperative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2020.