AnalgesiaPhase 2NCT02820610
Intraperitoneal Analgesia in Pediatric Laparoscopy
A Phase 2 study testing Dexmedetomidine, Magnesium Sulfate and Normal saline 0.9 % in people with Analgesia, run by Assiut University at 1 site in Egypt.
Trial summary
It is important to keep children undergoing laparoscopic surgery pain free with rapid return to normal activity. Read more about this study
- Who is it for?
- Ages 1 year to 6 years, men only
- Conditions the study is for
- Analgesia
- What is being tested?
- Dexmedetomidine, Magnesium Sulfate and Normal saline 0.9 %
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2016to Sep 2019
- Phase
- Phase 2
- 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 6 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- age (1 to 6 years)
- ASA physical status I or II.
- scheduled for laparoscopic hernia repair under general anesthesia.
Who cannot join
- Allergy to study drugs,
- Receiving chronic pain treatment, antiepileptic therapy or magnesium therapy,
- sever hepatic or renal impairment,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine Versus Magnesium Sulfate as an Adjuvant to Intraperitoneal Bupivacaine for Pain Relief in Children Undergoing Laparoscopic Herniorrhaphy: a Randomized Controlled Study.
It is important to keep children undergoing laparoscopic surgery pain free with rapid return to normal activity.
Read the detailed description
Pain following laparoscopy is less intense than after laparotomy. Nevertheless, laparoscopy is not pain free and control of post-laparoscopy pain remains a major concern. The exact cause of such pain remains uncertain, and yet, diaphragmatic irritation and peritoneal stretching associated with gas insufflation may be responsible for shoulder and diffuse abdominal pain.
additionally poor pain control could limit the activity of children following laparoscopic surgery.
- Conditions
- Analgesia
- Being tested
- Dexmedetomidine, Magnesium Sulfate, Normal saline 0.9 %
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Presidx
2 mg/kg bupivacaine 0.5% and 1 ug/kg of dexamedetomidine diluted in normal saline 0.9 % will instilled into the peritoneal cavity
Magnesium SulfateDrug
2 mg/kg bupivacaine 0.5% and 30 mg/kg of magnesium sulfate diluted in normal saline 0.9 % will instilled into the peritoneal cavity
Normal saline 0.9 %Drug
2 mg/kg bupivacaine 0.5% diluted in normal saline 0.9 % will instilled into the peritoneal cavity.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | 2 mg/kg bupivacaine 0.5% and 1 ug/kg of dexamedetomidine diluted in normal saline 0.9 % will instilled into the peritoneal cavity Receives: Drug: Dexmedetomidine |
| Magnesium sulfate | Active comparator | 2 mg/kg bupivacaine 0.5% and 30 mg/kg of magnesium sulfate diluted in normal saline 0.9 % will instilled into the peritoneal cavity Receives: Drug: Magnesium Sulfate |
| Control group | Placebo comparator | 2 mg/kg bupivacaine 0.5% diluted in normal saline 0.9 % will instilled into the peritoneal cavity. Receives: Drug: Normal saline 0.9 % |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
The Face Legs Activity Cry and Consolability (FLACC) pain score
Measured: 48 hr
Secondary outcomes (1)
the functional recovery
the functional activity score (FAS)
Measured: 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Assiut 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Mohamed Moeen Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02820610
- Sponsor's protocol ID
- SM62016
- Status last verified
- Jan 2020
- First submitted
- 29 Jun 2016
- Last updated
- 3 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Moeen SM, Wahba OM, Mandour AM, Ghany NA, Osman MA, Sabra TA, Takrouney MH, Moeen AM. Efficacy of dexmedetomidine versus magnesium sulfate as an adjuvant to intraperitoneal bupivacaine in pediatric laparoscopic surgery: a randomized clinical trial. Braz J Anesthesiol. 2024 Sep-Oct;74(5):744380. doi: 10.1016/j.bjane.2022.05.003. Epub 2022 May 23.
PubMed 35618084
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Versus Magnesium Sulfate as an Adjuvant to Intraperitoneal Bupivacaine for Pain Relief in Children Undergoing Laparoscopic Herniorrhaphy: a Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT02820610
- Acronym / sponsor ID
- SM62016
- Conditions
- Analgesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 1 Jul 2016 (estimated)
- 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.
It is important to keep children undergoing laparoscopic surgery pain free with rapid return to normal activity.
Detailed description
Pain following laparoscopy is less intense than after laparotomy. Nevertheless, laparoscopy is not pain free and control of post-laparoscopy pain remains a major concern. The exact cause of such pain remains uncertain, and yet, diaphragmatic irritation and peritoneal stretching associated with gas insufflation may be responsible for shoulder and diffuse abdominal pain.
additionally poor pain control could limit the activity of children following laparoscopic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: Dexmedetomidine2 mg/kg bupivacaine 0.5% and 1 ug/kg of dexamedetomidine diluted in normal saline 0.9 % will instilled into the peritoneal cavity |
| Magnesium sulfate | Active comparator | Drug: Magnesium Sulfate2 mg/kg bupivacaine 0.5% and 30 mg/kg of magnesium sulfate diluted in normal saline 0.9 % will instilled into the peritoneal cavity |
| Control group | Placebo comparator | Drug: Normal saline 0.9 %2 mg/kg bupivacaine 0.5% diluted in normal saline 0.9 % will instilled into the peritoneal cavity. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age (1 to 6 years)
- ASA physical status I or II.
- scheduled for laparoscopic hernia repair under general anesthesia.
Key exclusion criteria (3 listed)
- Allergy to study drugs,
- Receiving chronic pain treatment, antiepileptic therapy or magnesium therapy,
- sever hepatic or renal impairment,
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 |
|---|---|---|
| DexmedetomidineAlso: Presidx2 mg/kg bupivacaine 0.5% and 1 ug/kg of dexamedetomidine diluted in normal saline 0.9 % will instilled into the peritoneal cavity | Drug | Dexmedetomidine |
| Magnesium Sulfate2 mg/kg bupivacaine 0.5% and 30 mg/kg of magnesium sulfate diluted in normal saline 0.9 % will instilled into the peritoneal cavity | Drug | Magnesium sulfate |
| Normal saline 0.9 %2 mg/kg bupivacaine 0.5% diluted in normal saline 0.9 % will instilled into the peritoneal cavity. | Drug | Control group |
Primary outcome
Postoperative pain
Time frame: 48 hr
The Face Legs Activity Cry and Consolability (FLACC) pain score
1 secondary outcome
the functional recovery
Time frame: 48 hours after surgery
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 3 Jan 2020.
- Derived from this study: PubMed 35618084Moeen SM, Wahba OM, Mandour AM, Ghany NA, Osman MA, Sabra TA, Takrouney MH, Moeen AM. Efficacy of dexmedetomidine versus magnesium sulfate as an adjuvant to intraperitoneal bupivacaine in pediatric laparoscopic surgery: a randomized clinical trial. Braz J Anesthesiol. 2024 Sep-Oct;74(5):744380. doi: 10.1016/j.bjane.2022.05.003. Epub 2022 May 23.
- Individual participant dataSharing planned: Yes
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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 2 study testing Dexmedetomidine, Magnesium Sulfate and Normal saline 0.9 % in people with Analgesia, run by Assiut 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 3 inclusion and 3 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 3 Jan 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Postoperative pain (time frame: 48 hr). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02820610, which also lists 1 linked publication.
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 3 Jan 2020.