Emergence DeliriumPhase 3NCT06306040
Effect of Intravenous Nalbuphine and Magnesium Sulfate on Emergence Agitation in Pediatric
A Phase 3 study testing Nalbuphine Versus Magnesium Sulfate in people with Emergence Delirium, run by Assiut University.
Trial summary
Primary outcome: Measure The incidence of EA in children undergoing to hypospadias repair under general anesthesia is considered using Pediatric Anesthesia Emergence Delirium (PAED) scales. Read more about this study
- Who is it for?
- Ages 3 to 7 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Emergence Delirium
- What is being tested?
- Nalbuphine Versus Magnesium Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 2 Apr 2024to 30 Jan 2025
- Phase
- Phase 3
- 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 3 to 7 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- • Weight: 10 - 38 kg.
- Age: 3-7 years.
- ASA physical status: I-II.
- Operation: elective hypospadias repair under general anesthesia
Who cannot join
- • Parent's refusal.
- Anticipated difficult airway.
- Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia.
- History of developmental delay or mental retardation or any neurological disease.
- Known hypersensitivity to any drug used in this study.
- Children with co-morbid conditions like congenital heart disease, respiratory pathology, central nervous system disorders or renal pathology
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Intravenous Nalbuphine Versus Magnesium Sulfate on Emergence Agitation in Pediatric Patients Scheduled for Hypospadias Repair
- Primary outcome: Measure The incidence of EA in children undergoing to hypospadias repair under general anesthesia is considered using Pediatric Anesthesia Emergence Delirium (PAED) scales.
- Secondary outcome:
- Therefore, we designed a prospective, randomized, double-blind, single center study to investigate whether nalbuphine and/or magnesium sulphate can prevent EA after hypospadias repair in children under general anesthesia. In addition, the characteristics of anesthesia recovery and the incidence of adverse effects will also be evaluated in this study. Post-operative extubating time, interaction time, open eye time and emergence time. incidence of post-operative vomiting (PONV), laryngospasm, breath-holding, coughing, oxygen desaturation, and cardiac arrhythmias.
- Face, Legs, Activity, Cry and Consola Bility (FLACC) scale is used to determine post-operative pain score
- Parental satisfaction scores
Read the detailed description
Emergence agitation (EA), also referred to as emergence delirium, emergence excitement or inadequate emergence, is a frequent post-operative complication in pediatric patients receiving inhalational anesthetics. It's defined as an acute and fluctuating alteration of mental state and manifesting as agitation, confusion, disorientation, and hyperactivity during the transition from unconsciousness to full wakefulness. The incidence of EA is reported to be up to 20% in adult patients and up to 80% in children.
Although EA is self-limiting, it can induce potential problems in children, such as self-injury, bleeding and cracking of the wound, falling off of the indwelling catheter, and falling off of the bed, which can cause some difficulties for medical staff and serious anxiety for family members. In addition, children with EA are at a higher risk of post-hospitalization behavioral changes, which may last longer. Furthermore, EA treatment increases the burden on healthcare providers and increases the medical expenses of patients. EA commonly occurs after the most common surgeries in children like adenoidectomy, tonsillectomy, hernioplasty and hypospadias repair. Therefore, implementing effective measures to prevent EA in children undergoing these types of surgeries is crucial. Although the underlying mechanisms of EA remain unclear, the mechanisms may be related to pre-operative anxiety, inhaled anesthetics (sevoflurane or desflurane), surgery type (ophthalmology or otolaryngology procedure), and younger age.
Some pharmacological interventions have been used to prevent and treat EA. Previous studies have demonstrated that propofol, benzodiazepines, α2 agonists, and opioids can prevent EA in children to varying degrees. However, these medications may lead to respiratory depression, delay in anesthesia recovery and post-anesthesia care unit stay, and other adverse reactions. Thus, the most favorable prophylactic treatment to decrease such an incidence remains unknown, and the ideal approaches to prevent EA merit further exploration.
Nalbuphine is a synthetic opioid receptor agonist-antagonist (agonist К receptor, antagonistic part μ receptor) that can produce a central analgesic effect and partial sedation. Nalbuphine is a medication that is indicated for moderate to severe pain where the patient requires an opioid agent, and other alternative treatments have been insufficient. The inhibitory effect of nalbuphine on respiration is slight and it has a capping effect. Owing to these advantages, it is widely used in pediatric surgical analgesia.
Magnesium sulphate, an antagonist of N-methyl-D-aspartate (NMDA) glutamate receptors, has been reported to improve hypo-magnesia and pre-eclampsia. Recently, magnesium sulphate has been gradually used as an adjuvant for sedation and analgesia during general anesthesia. Magnesium sulphate is a medication used to manage and treat multiple clinical conditions.
- Conditions
- Emergence Delirium
- Being tested
- Nalbuphine Versus Magnesium Sulfate
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nalbuphine Versus Magnesium SulfateDrug
Also called analgesic effect on emergency agitation
Nalbuphine is a synthetic opioid receptor agonist-antagonist (agonist К receptor, antagonistic part μ receptor) that can produce a central analgesic effect and partial sedation. Nalbuphine is a medication that is indicated for moderate to severe pain where the patient requires an opioid agent, and other alternative treatments have been insufficient. The inhibitory effect of nalbuphine on respiration is slight and it has a capping effect. Owing to these advantages, it is widely used in pediatric surgical analgesia.
Magnesium sulphate, an antagonist of N-methyl-D-aspartate (NMDA) glutamate receptors, has been reported to improve hypo-magnesia and pre-eclampsia. Recently, magnesium sulphate has been gradually used as an adjuvant for sedation and analgesia during general anesthesia. Magnesium sulphate is a medication used to manage and treat multiple clinical conditions.
| Study group | Role | What they receive |
|---|---|---|
| • Group N (Nalbuphine group n=35 ) | Experimental | administrate nalbuphine 0.1 mg/kg nalbuphine diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery (injected once) dose Receives: Drug: Nalbuphine Versus Magnesium Sulfate |
| • Group M (Magnesium sulfate group n=35 ) | Experimental | administrate magnesium sulfate once 30 mg/kg Magnesium sulphate diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery Receives: Drug: Nalbuphine Versus Magnesium Sulfate |
| Group C (Control group n=35 ): | Experimental | administrate 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery Receives: Drug: Nalbuphine Versus Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare between analgesia effect on pediatric patient
Measure The incidence of EA in children undergoing to hypospadias repair under general anesthesia is considered using Pediatric Anesthesia Emergence Delirium (PAED) scales.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start2 Apr 2024 (estimated)
- Primary completion3 Nov 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Emergence DeliriumStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Group C (Control group n=35 ): 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery * Group M (Magnesium sulfate group n=35 ): 30 mg/kg Magnesium sulphate diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery * Group N (Nalbuphine group n=35 ): 0.1 mg/kg nalbuphine diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma alzahraa Mustafa Abdelbary Thabet, Assiut University
- Investigators
- Abualauon M Mohamed Abdelmohsen Rashwan, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306040
- Sponsor's protocol ID
- Analgesia effect as on EA
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee SJ, Sung TY. Emergence agitation: current knowledge and unresolved questions. Korean J Anesthesiol. 2020 Dec;73(6):471-485. doi: 10.4097/kja.20097. Epub 2020 Mar 25.
PubMed 32209961Dahmani S, Stany I, Brasher C, Lejeune C, Bruneau B, Wood C, Nivoche Y, Constant I, Murat I. Pharmacological prevention of sevoflurane- and desflurane-related emergence agitation in children: a meta-analysis of published studies. Br J Anaesth. 2010 Feb;104(2):216-23. doi: 10.1093/bja/aep376. Epub 2010 Jan 3.
PubMed 20047899Yu D, Chai W, Sun X, Yao L. Emergence agitation in adults: risk factors in 2,000 patients. Can J Anaesth. 2010 Sep;57(9):843-8. doi: 10.1007/s12630-010-9338-9. Epub 2010 Jun 5.
PubMed 20526708Choi EK, Park S, Park KB, Kwak KH, Park S. Postoperative emergence agitation and intraoperative sevoflurane sedation under caudal block in children: a randomized comparison of two sevoflurane doses. Anesth Pain Med (Seoul). 2019 Oct 31;14(4):434-440. doi: 10.17085/apm.2019.14.4.434.
PubMed 33329774Zhang YZ, Wei XL, Tang B, Qin YY, Ou M, Jiang XH, Tan YF, Ye MY. The Effects of Different Doses of Alfentanil and Dexmedetomidine on Prevention of Emergence Agitation in Pediatric Tonsillectomy and Adenoidectomy Surgery. Front Pharmacol. 2022 Feb 2;13:648802. doi: 10.3389/fphar.2022.648802. eCollection 2022.
PubMed 35185554Kim J, Byun SH, Kim JW, Kim JY, Kim YJ, Choi N, Lee BS, Yu S, Kim E. Behavioral changes after hospital discharge in preschool children experiencing emergence delirium after general anesthesia: A prospective observational study. Paediatr Anaesth. 2021 Oct;31(10):1056-1064. doi: 10.1111/pan.14259. Epub 2021 Aug 6.
PubMed 34309126Voepel-Lewis T, Malviya S, Tait AR. A prospective cohort study of emergence agitation in the pediatric postanesthesia care unit. Anesth Analg. 2003 Jun;96(6):1625-1630. doi: 10.1213/01.ANE.0000062522.21048.61.
PubMed 12760985Mason KP. Paediatric emergence delirium: a comprehensive review and interpretation of the literature. Br J Anaesth. 2017 Mar 1;118(3):335-343. doi: 10.1093/bja/aew477.
PubMed 28203739Kanaya A. Emergence agitation in children: risk factors, prevention, and treatment. J Anesth. 2016 Apr;30(2):261-7. doi: 10.1007/s00540-015-2098-5. Epub 2015 Nov 24.
PubMed 26601849Jalili S, Esmaeeili A, Kamali K, Rashtchi V. Comparison of effects of propofol and ketofol (Ketamine-Propofol mixture) on emergence agitation in children undergoing tonsillectomy. Afr Health Sci. 2019 Mar;19(1):1736-1744. doi: 10.4314/ahs.v19i1.50.
PubMed 31149004Kawai M, Kurata S, Sanuki T, Mishima G, Kiriishi K, Watanabe T, Ozaki-Honda Y, Yoshida M, Okayasu I, Ayuse T, Tanoue N, Ayuse T. The effect of midazolam administration for the prevention of emergence agitation in pediatric patients with extreme fear and non-cooperation undergoing dental treatment under sevoflurane anesthesia, a double-blind, randomized study. Drug Des Devel Ther. 2019 May 17;13:1729-1737. doi: 10.2147/DDDT.S198123. eCollection 2019.
PubMed 31190751Kim SY, Kim JM, Lee JH, Song BM, Koo BN. Efficacy of intraoperative dexmedetomidine infusion on emergence agitation and quality of recovery after nasal surgery. Br J Anaesth. 2013 Aug;111(2):222-8. doi: 10.1093/bja/aet056. Epub 2013 Mar 22.
PubMed 23524149Cravero JP, Beach M, Thyr B, Whalen K. The effect of small dose fentanyl on the emergence characteristics of pediatric patients after sevoflurane anesthesia without surgery. Anesth Analg. 2003 Aug;97(2):364-367. doi: 10.1213/01.ANE.0000070227.78670.43.
PubMed 12873918Kubica-Cielinska A, Zielinska M. The use of nalbuphine in paediatric anaesthesia. Anaesthesiol Intensive Ther. 2015;47(3):252-6. doi: 10.5603/AIT.2015.0036.
PubMed 26165241Shin D, Kim S, Kim CS, Kim HS. Postoperative pain management using intravenous patient-controlled analgesia for pediatric patients. J Craniofac Surg. 2001 Mar;12(2):129-33. doi: 10.1097/00001665-200103000-00007.
PubMed 11314621
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Nalbuphine Versus Magnesium Sulfate on Emergence Agitation in Pediatric Patients Scheduled for Hypospadias Repair
- ClinicalTrials.gov ID
- NCT06306040
- Acronym / sponsor ID
- Analgesia effect as on EA
- Conditions
- Emergence Delirium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 2 Apr 2024 (estimated)
- Primary completion
- 3 Nov 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 12 Mar 2024 (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.
- Primary outcome: Measure The incidence of EA in children undergoing to hypospadias repair under general anesthesia is considered using Pediatric Anesthesia Emergence Delirium (PAED) scales.
- Secondary outcome:
- Therefore, we designed a prospective, randomized, double-blind, single center study to investigate whether nalbuphine and/or magnesium sulphate can prevent EA after hypospadias repair in children under general anesthesia. In addition, the characteristics of anesthesia recovery and the incidence of adverse effects will also be evaluated in this study. Post-operative extubating time, interaction time, open eye time and emergence time. incidence of post-operative vomiting (PONV), laryngospasm, breath-holding, coughing, oxygen desaturation, and cardiac arrhythmias.
- Face, Legs, Activity, Cry and Consola Bility (FLACC) scale is used to determine post-operative pain score
- Parental satisfaction scores
Detailed description
Emergence agitation (EA), also referred to as emergence delirium, emergence excitement or inadequate emergence, is a frequent post-operative complication in pediatric patients receiving inhalational anesthetics. It's defined as an acute and fluctuating alteration of mental state and manifesting as agitation, confusion, disorientation, and hyperactivity during the transition from unconsciousness to full wakefulness. The incidence of EA is reported to be up to 20% in adult patients and up to 80% in children.
Although EA is self-limiting, it can induce potential problems in children, such as self-injury, bleeding and cracking of the wound, falling off of the indwelling catheter, and falling off of the bed, which can cause some difficulties for medical staff and serious anxiety for family members. In addition, children with EA are at a higher risk of post-hospitalization behavioral changes, which may last longer. Furthermore, EA treatment increases the burden on healthcare providers and increases the medical expenses of patients. EA commonly occurs after the most common surgeries in children like adenoidectomy, tonsillectomy, hernioplasty and hypospadias repair. Therefore, implementing effective measures to prevent EA in children undergoing these types of surgeries is crucial. Although the underlying mechanisms of EA remain unclear, the mechanisms may be related to pre-operative anxiety, inhaled anesthetics (sevoflurane or desflurane), surgery type (ophthalmology or otolaryngology procedure), and younger age.
Some pharmacological interventions have been used to prevent and treat EA. Previous studies have demonstrated that propofol, benzodiazepines, α2 agonists, and opioids can prevent EA in children to varying degrees. However, these medications may lead to respiratory depression, delay in anesthesia recovery and post-anesthesia care unit stay, and other adverse reactions. Thus, the most favorable prophylactic treatment to decrease such an incidence remains unknown, and the ideal approaches to prevent EA merit further exploration.
Nalbuphine is a synthetic opioid receptor agonist-antagonist (agonist К receptor, antagonistic part μ receptor) that can produce a central analgesic effect and partial sedation. Nalbuphine is a medication that is indicated for moderate to severe pain where the patient requires an opioid agent, and other alternative treatments have been insufficient. The inhibitory effect of nalbuphine on respiration is slight and it has a capping effect. Owing to these advantages, it is widely used in pediatric surgical analgesia.
Magnesium sulphate, an antagonist of N-methyl-D-aspartate (NMDA) glutamate receptors, has been reported to improve hypo-magnesia and pre-eclampsia. Recently, magnesium sulphate has been gradually used as an adjuvant for sedation and analgesia during general anesthesia. Magnesium sulphate is a medication used to manage and treat multiple clinical conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- * Group C (Control group n=35 ): 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery * Group M (Magnesium sulfate group n=35 ): 30 mg/kg Magnesium sulphate diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery * Group N (Nalbuphine group n=35 ): 0.1 mg/kg nalbuphine diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery
| Arm | Type | Receives |
|---|---|---|
| • Group N (Nalbuphine group n=35 ) | Experimental | Drug: Nalbuphine Versus Magnesium Sulfateadministrate nalbuphine 0.1 mg/kg nalbuphine diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery (injected once) dose |
| • Group M (Magnesium sulfate group n=35 ) | Experimental | Drug: Nalbuphine Versus Magnesium Sulfateadministrate magnesium sulfate once 30 mg/kg Magnesium sulphate diluted to 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery |
| Group C (Control group n=35 ): | Experimental | Drug: Nalbuphine Versus Magnesium Sulfateadministrate 10 ml isotonic saline will be injected intravenously before 30 min from end of surgery |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- • Weight: 10 - 38 kg.
Key exclusion criteria (6 listed)
- • Parent's refusal.
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 |
|---|---|---|
| Nalbuphine Versus Magnesium SulfateAlso: analgesic effect on emergency agitationNalbuphine is a synthetic opioid receptor agonist-antagonist (agonist К receptor, antagonistic part μ receptor) that can produce a central analgesic effect and partial sedation. Nalbuphine is a medication that is indicated for moderate to severe pain where the patient requires an opioid agent, and other alternative treatments have been insufficient. The inhibitory effect of nalbuphine on respiration is slight and it has a capping effect. Owing to these advantages, it is widely used in pediatric surgical analgesia. Magnesium sulphate, an antagonist of N-methyl-D-aspartate (NMDA) glutamate receptors, has been reported to improve hypo-magnesia and pre-eclampsia. Recently, magnesium sulphate has been gradually used as an adjuvant for sedation and analgesia during general anesthesia. Magnesium sulphate is a medication used to manage and treat multiple clinical conditions. | Drug | Group C (Control group n=35 ):, • Group M (Magnesium sulfate group n=35 ), • Group N (Nalbuphine group n=35 ) |
Primary outcome
compare between analgesia effect on pediatric patient
Time frame: baseline
Measure The incidence of EA in children undergoing to hypospadias repair under general anesthesia is considered using Pediatric Anesthesia Emergence Delirium (PAED) scales.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 32209961Lee SJ, Sung TY. Emergence agitation: current knowledge and unresolved questions. Korean J Anesthesiol. 2020 Dec;73(6):471-485. doi: 10.4097/kja.20097. Epub 2020 Mar 25.
- Background: PubMed 20047899Dahmani S, Stany I, Brasher C, Lejeune C, Bruneau B, Wood C, Nivoche Y, Constant I, Murat I. Pharmacological prevention of sevoflurane- and desflurane-related emergence agitation in children: a meta-analysis of published studies. Br J Anaesth. 2010 Feb;104(2):216-23. doi: 10.1093/bja/aep376. Epub 2010 Jan 3.
- Background: PubMed 20526708Yu D, Chai W, Sun X, Yao L. Emergence agitation in adults: risk factors in 2,000 patients. Can J Anaesth. 2010 Sep;57(9):843-8. doi: 10.1007/s12630-010-9338-9. Epub 2010 Jun 5.
- Background: PubMed 33329774Choi EK, Park S, Park KB, Kwak KH, Park S. Postoperative emergence agitation and intraoperative sevoflurane sedation under caudal block in children: a randomized comparison of two sevoflurane doses. Anesth Pain Med (Seoul). 2019 Oct 31;14(4):434-440. doi: 10.17085/apm.2019.14.4.434.
- Background: PubMed 35185554Zhang YZ, Wei XL, Tang B, Qin YY, Ou M, Jiang XH, Tan YF, Ye MY. The Effects of Different Doses of Alfentanil and Dexmedetomidine on Prevention of Emergence Agitation in Pediatric Tonsillectomy and Adenoidectomy Surgery. Front Pharmacol. 2022 Feb 2;13:648802. doi: 10.3389/fphar.2022.648802. eCollection 2022.
- Background: PubMed 34309126Kim J, Byun SH, Kim JW, Kim JY, Kim YJ, Choi N, Lee BS, Yu S, Kim E. Behavioral changes after hospital discharge in preschool children experiencing emergence delirium after general anesthesia: A prospective observational study. Paediatr Anaesth. 2021 Oct;31(10):1056-1064. doi: 10.1111/pan.14259. Epub 2021 Aug 6.
- Background: PubMed 12760985Voepel-Lewis T, Malviya S, Tait AR. A prospective cohort study of emergence agitation in the pediatric postanesthesia care unit. Anesth Analg. 2003 Jun;96(6):1625-1630. doi: 10.1213/01.ANE.0000062522.21048.61.
- Background: PubMed 28203739Mason KP. Paediatric emergence delirium: a comprehensive review and interpretation of the literature. Br J Anaesth. 2017 Mar 1;118(3):335-343. doi: 10.1093/bja/aew477.
- Background: PubMed 26601849Kanaya A. Emergence agitation in children: risk factors, prevention, and treatment. J Anesth. 2016 Apr;30(2):261-7. doi: 10.1007/s00540-015-2098-5. Epub 2015 Nov 24.
- Background: PubMed 31149004Jalili S, Esmaeeili A, Kamali K, Rashtchi V. Comparison of effects of propofol and ketofol (Ketamine-Propofol mixture) on emergence agitation in children undergoing tonsillectomy. Afr Health Sci. 2019 Mar;19(1):1736-1744. doi: 10.4314/ahs.v19i1.50.
- Background: PubMed 31190751Kawai M, Kurata S, Sanuki T, Mishima G, Kiriishi K, Watanabe T, Ozaki-Honda Y, Yoshida M, Okayasu I, Ayuse T, Tanoue N, Ayuse T. The effect of midazolam administration for the prevention of emergence agitation in pediatric patients with extreme fear and non-cooperation undergoing dental treatment under sevoflurane anesthesia, a double-blind, randomized study. Drug Des Devel Ther. 2019 May 17;13:1729-1737. doi: 10.2147/DDDT.S198123. eCollection 2019.
- Background: PubMed 23524149Kim SY, Kim JM, Lee JH, Song BM, Koo BN. Efficacy of intraoperative dexmedetomidine infusion on emergence agitation and quality of recovery after nasal surgery. Br J Anaesth. 2013 Aug;111(2):222-8. doi: 10.1093/bja/aet056. Epub 2013 Mar 22.
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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.
Abualauon M Mohamed Abdelmohsen Rashwan, Lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nalbuphine Versus Magnesium Sulfate in people with Emergence Delirium, run by Assiut University.
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 6 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: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fatma Alzahraa M Mustafa Abdulbari, resident (00201014363853, zahraamustafa22@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare between analgesia effect on pediatric patient (time frame: baseline). 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 NCT06306040, which also lists 24 linked publications.
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 12 Mar 2024.