Specified SedativePhase 4NCT02463929
Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric
A Phase 4 study testing Diphenhydramine, normal saline and Ketamine in people with Specified Sedative and Hypnotic, run by Universitas Diponegoro.
Trial summary
The purpose of this study is to investigate the effect of diphenhydramine on the prevention of sevoflurane induced emergence delirium/ agitation in pediatrics. The Investigators hypothesis is that it reduce the incidence of sevoflurane induced emergence delirium/ agitation. Read more about this study
- Who is it for?
- Ages 2 to 24 months
- Conditions the study is for
- Specified Sedative, Hypnotic
- What is being tested?
- Diphenhydramine, normal saline and Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Apr 2014to Jul 2014
- 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 2 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA I or 2
- no cardiovascular, respiratory or neurologic congenital anomalies
- no allergic reactions, or any contraindication to drugs used in this trial ever documented
Who cannot join
- congenital anomalies recognized/diagnosed during trial procedures
- hemmorhage > 15% EBV
- shock or other major anesthesia or surgical complications during trial procedures (hipoxia, atelectasis, unintended disconection of ETT or IV line)
About this study
The purpose of this study is to investigate the effect of diphenhydramine on the prevention of sevoflurane induced emergence delirium/ agitation in pediatrics. The Investigators hypothesis is that it reduce the incidence of sevoflurane induced emergence delirium/ agitation.
Read the detailed description
This is an experimental clinical trial in double-blinded randomized controlled design on 50 children aged 10 months to 21 months who underwent general anesthesia with sevoflurane for labioplasty surgery. Fifteen minutes before inhalation anesthetics were discontinued, the subjects were randomly given a placebo or a single dose of diphenhydramine 0, 5 mg / kg intravenously. Subjects were extubated and observed in the recovered space conscious for any agitation or emergence delirium and feasability to return to the ward. Agitation or emergence delirium was assessed by the Pediatric Emergence Agitation and Delirium Score (PAEDS) whereas feasability to return to the ward scored with the Steward score. When PAEDS> 10 patients were assessed to be agitated or having emergence delirium and administeres rescue tranquilizer ketamine 0.1 mg / kg. Total rescue tranquilizers and clinically significant adverse effects of drugs also recorded.
- Conditions
- Specified Sedative, Hypnotic
- Being tested
- Diphenhydramine, normal saline, Ketamine, Sevoflurane, Bupivacaine
- Keywords
- Diphenhydramine, emergence agitation, pediatric anesthesia, PAEDS, Withdrawal
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiphenhydramineDrug
Intravenous Injection
normal salineDrug
Also called NaCl 0,9%
Intravenous Injection
KetamineDrug
Ketamine 0,1 mg/kg intravenously used as rescue tranquilizer if the subject becomes agitated, repeated dose of 0,05 mg/kg every minute can be given if the agitation does not resolve, maximum ketamine dose for tranquilizer 0,25 mg/kg to prevent deep sedation
SevofluraneDrug
Sevoflurane as single sedation agent for general anesthesia in both arm. 8% Sevoflurane in 100% oxygen used as induction agent, and 2% sevoflurane in 50% oxygen used as maintenance agent
BupivacaineDrug
Bilateral extraoral infraorbital nerve block with 0,125% Bupivacaine as analgetic for operation and post operation.
| Study group | Role | What they receive |
|---|---|---|
| diphenhydramine | Experimental | Subject sedated with sevoflurane, and given bilateral extraoral infraorbital block with 0,125% bupivacaine. Subject injected 0,5mg/kg diphenhydramine intravenously, 15 minutes prior to discontinuation of sevoflurane. If subject develop agitation, 0,1 mg/kg ketamine is administered Receives: Drug: Diphenhydramine; Drug: Ketamine; Drug: Sevoflurane; Drug: Bupivacaine |
| control | Placebo comparator | Subject sedated with sevoflurane, and given bilateral extraoral infraorbital block with 0,125% bupivacaine. Subject injected 0,5cc/kg normal saline intravenously, 15 minutes prior to discontinuation of sevoflurane. If subject develop agitation, 0,1 mg/kg ketamine is administered Receives: Drug: normal saline; Drug: Ketamine; Drug: Sevoflurane; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of sevoflurane induced post anesthesia agitation
Measured: 10 minutes post extubation
Secondary outcomes (8)
Amount of rescue Ketamine used
Administration of 0,1 mg/kg ketamine intravenously if the patient gets agitated
Measured: 1 minute post extubation, at emergence, 15 minute post extubation
Significant adverse events
Any respiratory or cardiovascular events during observation in recovery room
Measured: 1 minute post extubation, at emergence, 15 minute post extubation
Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
Measured: 1 minute post extubation
Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
Measured: at emergence
Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
Measured: 15 minute post extubation
Incidence of sevoflurane induced post anesthesia agitation
Measured: 1 minute post extubation
Incidence of sevoflurane induced post anesthesia agitation
Measured: 15 minute post extubation
Length of stay in recovery room
Measured: up to 15 minutes post extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2015 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Specified SedativeStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Diponegoro
- Sponsor type
- University, hospital or other
- Collaborators
- Permata Sari Hospital for Plastic Surgery
- Responsible party
- Principal investigator, Ika Cahyo Purnomo, Universitas Diponegoro
- Investigators
- Johan Mr Arifin, dr, Study director, Universitas Diponegoro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02463929
- Sponsor's protocol ID
- UDiponegoro
- Status last verified
- Jun 2015
- First submitted
- 18 May 2015
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Varughese AM, Rampersad SE, Whitney GM, Flick RP, Anton B, Heitmiller ES. Quality and safety in pediatric anesthesia. Anesth Analg. 2013 Dec;117(6):1408-18. doi: 10.1213/ANE.0b013e318294fb4a.
PubMed 24257392Cohen IT, Finkel JC, Hannallah RS, Hummer KA, Patel KM. The effect of fentanyl on the emergence characteristics after desflurane or sevoflurane anesthesia in children. Anesth Analg. 2002 May;94(5):1178-81, table of contents. doi: 10.1097/00000539-200205000-00023.
PubMed 11973185Koner O, Ture H, Mercan A, Menda F, Sozubir S. Effects of hydroxyzine-midazolam premedication on sevoflurane-induced paediatric emergence agitation: a prospective randomised clinical trial. Eur J Anaesthesiol. 2011 Sep;28(9):640-5. doi: 10.1097/EJA.0b013e328344db1a.
PubMed 21822077Abdallah C, Hannallah R. Premedication of the child undergoing surgery. Middle East J Anaesthesiol. 2011 Jun;21(2):165-74. No abstract available.
PubMed 22435268Aouad MT, Nasr VG. Emergence agitation in children: an update. Curr Opin Anaesthesiol. 2005 Dec;18(6):614-9. doi: 10.1097/01.aco.0000188420.84763.35.
PubMed 16534301Simons FE, Simons KJ. Clinical pharmacology of H1-antihistamines. Clin Allergy Immunol. 2002;17:141-78. No abstract available.
PubMed 12113216
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric
- ClinicalTrials.gov ID
- NCT02463929
- Acronym / sponsor ID
- UDiponegoro
- Conditions
- Specified Sedative, Hypnotic
- Keywords
- Diphenhydramine, emergence agitation, pediatric anesthesia, PAEDS, Withdrawal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitas DiponegoroUniversity, hospital or other
- Collaborators
- Permata Sari Hospital for Plastic Surgery
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Jun 2015 (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.
The purpose of this study is to investigate the effect of diphenhydramine on the prevention of sevoflurane induced emergence delirium/ agitation in pediatrics. The Investigators hypothesis is that it reduce the incidence of sevoflurane induced emergence delirium/ agitation.
Detailed description
This is an experimental clinical trial in double-blinded randomized controlled design on 50 children aged 10 months to 21 months who underwent general anesthesia with sevoflurane for labioplasty surgery. Fifteen minutes before inhalation anesthetics were discontinued, the subjects were randomly given a placebo or a single dose of diphenhydramine 0, 5 mg / kg intravenously. Subjects were extubated and observed in the recovered space conscious for any agitation or emergence delirium and feasability to return to the ward. Agitation or emergence delirium was assessed by the Pediatric Emergence Agitation and Delirium Score (PAEDS) whereas feasability to return to the ward scored with the Steward score. When PAEDS> 10 patients were assessed to be agitated or having emergence delirium and administeres rescue tranquilizer ketamine 0.1 mg / kg. Total rescue tranquilizers and clinically significant adverse effects of drugs also recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diphenhydramine | Experimental | Drug: Diphenhydramine, Drug: Ketamine, Drug: Sevoflurane, Drug: BupivacaineSubject sedated with sevoflurane, and given bilateral extraoral infraorbital block with 0,125% bupivacaine. Subject injected 0,5mg/kg diphenhydramine intravenously, 15 minutes prior to discontinuation of sevoflurane. If subject develop agitation, 0,1 mg/kg ketamine is administered |
| control | Placebo comparator | Drug: normal saline, Drug: Ketamine, Drug: Sevoflurane, Drug: BupivacaineSubject sedated with sevoflurane, and given bilateral extraoral infraorbital block with 0,125% bupivacaine. Subject injected 0,5cc/kg normal saline intravenously, 15 minutes prior to discontinuation of sevoflurane. If subject develop agitation, 0,1 mg/kg ketamine is administered |
Who may qualify
- Ages
- 2 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA I or 2
- no cardiovascular, respiratory or neurologic congenital anomalies
- no allergic reactions, or any contraindication to drugs used in this trial ever documented
Key exclusion criteria (3 listed)
- congenital anomalies recognized/diagnosed during trial procedures
- hemmorhage > 15% EBV
- shock or other major anesthesia or surgical complications during trial procedures (hipoxia, atelectasis, unintended disconection of ETT or IV line)
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 |
|---|---|---|
| DiphenhydramineIntravenous Injection | Drug | diphenhydramine |
| normal salineAlso: NaCl 0,9%Intravenous Injection | Drug | control |
| KetamineKetamine 0,1 mg/kg intravenously used as rescue tranquilizer if the subject becomes agitated, repeated dose of 0,05 mg/kg every minute can be given if the agitation does not resolve, maximum ketamine dose for tranquilizer 0,25 mg/kg to prevent deep sedation | Drug | control, diphenhydramine |
| SevofluraneSevoflurane as single sedation agent for general anesthesia in both arm. 8% Sevoflurane in 100% oxygen used as induction agent, and 2% sevoflurane in 50% oxygen used as maintenance agent | Drug | control, diphenhydramine |
| BupivacaineBilateral extraoral infraorbital nerve block with 0,125% Bupivacaine as analgetic for operation and post operation. | Drug | control, diphenhydramine |
Primary outcome
Incidence of sevoflurane induced post anesthesia agitation
Time frame: 10 minutes post extubation
8 secondary outcomes
Amount of rescue Ketamine used
Time frame: 1 minute post extubation, at emergence, 15 minute post extubation
Significant adverse events
Time frame: 1 minute post extubation, at emergence, 15 minute post extubation
Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
Time frame: 1 minute post extubation
Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
Time frame: at emergence
Mean Pediatric Emergence Agitation and Delirium Score (PAEDS)
Time frame: 15 minute post extubation
Incidence of sevoflurane induced post anesthesia agitation
Time frame: 1 minute post extubation
Incidence of sevoflurane induced post anesthesia agitation
Time frame: 15 minute post extubation
Length of stay in recovery room
Time frame: up to 15 minutes post extubation
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 4 Jun 2015.
- Background: PubMed 24257392Varughese AM, Rampersad SE, Whitney GM, Flick RP, Anton B, Heitmiller ES. Quality and safety in pediatric anesthesia. Anesth Analg. 2013 Dec;117(6):1408-18. doi: 10.1213/ANE.0b013e318294fb4a.
- Background: PubMed 11973185Cohen IT, Finkel JC, Hannallah RS, Hummer KA, Patel KM. The effect of fentanyl on the emergence characteristics after desflurane or sevoflurane anesthesia in children. Anesth Analg. 2002 May;94(5):1178-81, table of contents. doi: 10.1097/00000539-200205000-00023.
- Background: PubMed 21822077Koner O, Ture H, Mercan A, Menda F, Sozubir S. Effects of hydroxyzine-midazolam premedication on sevoflurane-induced paediatric emergence agitation: a prospective randomised clinical trial. Eur J Anaesthesiol. 2011 Sep;28(9):640-5. doi: 10.1097/EJA.0b013e328344db1a.
- Background: PubMed 22435268Abdallah C, Hannallah R. Premedication of the child undergoing surgery. Middle East J Anaesthesiol. 2011 Jun;21(2):165-74. No abstract available.
- Background: PubMed 16534301Aouad MT, Nasr VG. Emergence agitation in children: an update. Curr Opin Anaesthesiol. 2005 Dec;18(6):614-9. doi: 10.1097/01.aco.0000188420.84763.35.
- Background: PubMed 12113216Simons FE, Simons KJ. Clinical pharmacology of H1-antihistamines. Clin Allergy Immunol. 2002;17:141-78. No abstract available.
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.
Johan Mr Arifin, dr study director
Universitas Diponegoro
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Diphenhydramine, normal saline and Ketamine in people with Specified Sedative and Hypnotic, run by Universitas Diponegoro.
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 4 Jun 2015. 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. 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 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?
Incidence of sevoflurane induced post anesthesia agitation (time frame: 10 minutes post extubation). 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 NCT02463929, which also lists 6 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 4 Jun 2015.