Respiratory Tract DiseasePhase 2/3NCT02929524
Intranasal Ketamine as a Sedative for Venipuncture
A Phase 2/3 study testing Ketamine in people with Respiratory Tract Disease and Acute Pain, run by Hospital de Clinicas de Porto Alegre.
Trial summary
Randomized clinical trial, controlled, double-blind, parallel two-arm. Read more about this study
- Who is it for?
- Ages 3 months to 12 years
- Conditions the study is for
- Respiratory Tract Disease, Acute Pain, Diseases of the Digestive System
- What is being tested?
- Ketamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Oct 2016
- Phase
- Phase 2/3
- 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 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children hospitalized in the Pediatric Inpatient Units, with the presence of legal guardian;
- Aged 3 months to 12 years;
- Requiring venipuncture independent research.
Who cannot join
- Severe neurological sequelae;
- Patients who need immediate venipuncture at risk;
- Presence of active nosebleeds;
- Patients using drugs sedative and analgesic continuos;
- Children who have experienced clinical change with ketamine.
About this study
Official title: Intranasal Ketamine for Peripheral Venous Puncture in Pediatric Patients: A Randomized Double Blind and Placebo Controlled Study
Randomized clinical trial, controlled, double-blind, parallel two-arm.
Read the detailed description
Randomized, double-blind, placebo controlled study conducted at the Clinical Hospital of Porto Alegre between November / 15 and August / 16. This study was approved by the Ethics Committee of the Institution. Participated children requiring venipuncture randomized in the intervention group who received the ketamine IN 4 mg/kg and placebo saline group. The groups were compared: Puncture time, ease the nurse to perform the procedure, adverse events, changes in vital signs and perception of the companion.
- Being tested
- Ketamine, Placebo
- Keywords
- Ketamine, Intranasal administration, Pediatric nursing
- Medical subject headings
- Respiratory Tract Diseases, Acute Pain, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Intervention group
As indicated the use of sedative and after authorization of the person responsible, the child receives the intranasal solution. Before administration of the solution 2 hour and 24 hours after the procedure, must be recorded vital signs of the patient. A person with the help of a clock will make the time count. The nurse and the patient's family must respond to the study protocol questions
PlaceboDrug
Also called Saline group
As indicated the use of sedative and after authorization of the person responsible, the child receives the intranasal solution. Before administration of the solution 2 hour and 24 hours after the procedure, must be recorded vital signs of the patient. A person with the help of a clock will make the time count. The nurse and the patient's family must respond to the study protocol questions
| Study group | Role | What they receive |
|---|---|---|
| Ketamine group | Experimental | This group was used intranasal ketamine, syringes were made with 4 ml of the drug (50mg/ml), 1 randomized per patient. The validity stability and were 7 days after drawing the solution. The drug began to take effect in 10 minutes and lasted about 40 minutes. Receives: Drug: Ketamine |
| Placebo Group | Placebo comparator | This group was used intranasal saline, syringes were made with 4 ml of liquid 1 per patient randomized. The validity stability and were 7 days after drawing the solution. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased venipuncture Time
Measured: Expected 3 minutes difference between the 2 groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startApr 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract DiseaseStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jefferson Piva, Study director, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929524
- Sponsor's protocol ID
- 150424
- Status last verified
- Oct 2016
- First submitted
- 7 Oct 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Ketamine for Peripheral Venous Puncture in Pediatric Patients: A Randomized Double Blind and Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02929524
- Acronym / sponsor ID
- 150424
- Keywords
- Ketamine, Intranasal administration, Pediatric nursing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 11 Oct 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.
Randomized clinical trial, controlled, double-blind, parallel two-arm.
Detailed description
Randomized, double-blind, placebo controlled study conducted at the Clinical Hospital of Porto Alegre between November / 15 and August / 16. This study was approved by the Ethics Committee of the Institution. Participated children requiring venipuncture randomized in the intervention group who received the ketamine IN 4 mg/kg and placebo saline group. The groups were compared: Puncture time, ease the nurse to perform the procedure, adverse events, changes in vital signs and perception of the companion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine group | Experimental | Drug: KetamineThis group was used intranasal ketamine, syringes were made with 4 ml of the drug (50mg/ml), 1 randomized per patient. The validity stability and were 7 days after drawing the solution. The drug began to take effect in 10 minutes and lasted about 40 minutes. |
| Placebo Group | Placebo comparator | Drug: PlaceboThis group was used intranasal saline, syringes were made with 4 ml of liquid 1 per patient randomized. The validity stability and were 7 days after drawing the solution. |
Who may qualify
- Ages
- 3 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children hospitalized in the Pediatric Inpatient Units, with the presence of legal guardian;
- Aged 3 months to 12 years;
- Requiring venipuncture independent research.
Key exclusion criteria (5 listed)
- Severe neurological sequelae;
- Patients who need immediate venipuncture at risk;
- Presence of active nosebleeds;
- Patients using drugs sedative and analgesic continuos;
- Children who have experienced clinical change with ketamine.
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 |
|---|---|---|
| KetamineAlso: Intervention groupAs indicated the use of sedative and after authorization of the person responsible, the child receives the intranasal solution. Before administration of the solution 2 hour and 24 hours after the procedure, must be recorded vital signs of the patient. A person with the help of a clock will make the time count. The nurse and the patient's family must respond to the study protocol questions | Drug | Ketamine group |
| PlaceboAlso: Saline groupAs indicated the use of sedative and after authorization of the person responsible, the child receives the intranasal solution. Before administration of the solution 2 hour and 24 hours after the procedure, must be recorded vital signs of the patient. A person with the help of a clock will make the time count. The nurse and the patient's family must respond to the study protocol questions | Drug | Placebo Group |
Primary outcome
Decreased venipuncture Time
Time frame: Expected 3 minutes difference between the 2 groups
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 11 Oct 2016.
- Individual participant dataSharing planned: Undecided
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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.
Jefferson Piva study director
Hospital de Clinicas de Porto Alegre
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketamine in people with Respiratory Tract Disease and Acute Pain, run by Hospital de Clinicas de Porto Alegre.
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 5 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 11 Oct 2016. 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 combined 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.
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?
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?
Decreased venipuncture Time (time frame: Expected 3 minutes difference between the 2 groups). 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 11 Oct 2016.