PainPhase 4NCT06139380
Intranasal Ketamine Effectiveness in Reducing Intramuscular Injection Pain Before Sedation Among Children
A Phase 4 study testing Ketamine and Sterile water in people with Pain and Intranasal Ketamine, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Hypothesis: Intranasal administration of ketamine would reduce the intramuscular pain of ketamine injection in children who undergo procedural sedation and analgesia in the emergency department. Read more about this study
- Who is it for?
- Ages 12 months to 7 years
- Conditions the study is for
- Pain, Intranasal Ketamine
- What is being tested?
- Ketamine and Sterile water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteIran
- Study dates
- 2 Dec 2023to 31 May 2024
- 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 12 months to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children who need to undergo procedural sedation and analgesia
Who cannot join
- Weight over 33 Kg
- No Consent from parents/patient
- Needs immediate procedure due to patient's condition
- Growth/mental retardation
- Sensory deficit at the site of intramuscular injection
Trial locations and contacts
1 site in 1 country.
About this study
Hypothesis: Intranasal administration of ketamine would reduce the intramuscular pain of ketamine injection in children who undergo procedural sedation and analgesia in the emergency department.
Read the detailed description
Ketamine is a well-known medication in children's procedural sedation and analgesia. While it provides good analgesia along with sedation, its injection is painful and causes distress in children. Intranasal administration of Ketamine would reduce the intramuscular pain of ketamine injection in children who undergo procedural sedation and analgesia in the emergency department. This will also assess if intranasal administration would affect the depth of sedation and hospital length of stay of this group of patients.
- Conditions
- Pain, Intranasal Ketamine
- Being tested
- Ketamine, Sterile water
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
This is medication which is commonly used for sedation in the emergency department. At the analgesic dose, this medication can be used to reduce the pain via other routes such as intranasal.
Sterile waterDrug
Intranasal sterile water was administered via syringe.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal ketamine | Active comparator | Not described Receives: Drug: Ketamine |
| Intranasal sterile water | Placebo comparator | Not described Receives: Drug: Sterile water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intramuscular injection pain
This will be assessed at the time of injection using FLACC scale.
Measured: immediately after Intramuscular injection
Secondary outcomes (2)
Hospital stay duration
This will be assessed using modified Ramsay's sedation scale.
Measured: 1 hours on average
Adverse effects
This will be assessed using the standard definition of the adverse effects.
Measured: 1 hours on average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start2 Dec 2023
- Primary completion28 Apr 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-group parallel double blind randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadi Mirfazaelian, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139380
- Sponsor's protocol ID
- 9911307010
- Status last verified
- May 2024
- First submitted
- 6 Nov 2023
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Ketamine Effectiveness in Reducing Intramuscular Injection Pain Before Sedation Among Children
- ClinicalTrials.gov ID
- NCT06139380
- Acronym / sponsor ID
- 9911307010
- Conditions
- Pain, Intranasal Ketamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 2 Dec 2023 (actual)
- Primary completion
- 28 Apr 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 18 Nov 2023 (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.
Hypothesis: Intranasal administration of ketamine would reduce the intramuscular pain of ketamine injection in children who undergo procedural sedation and analgesia in the emergency department.
Detailed description
Ketamine is a well-known medication in children's procedural sedation and analgesia. While it provides good analgesia along with sedation, its injection is painful and causes distress in children. Intranasal administration of Ketamine would reduce the intramuscular pain of ketamine injection in children who undergo procedural sedation and analgesia in the emergency department. This will also assess if intranasal administration would affect the depth of sedation and hospital length of stay of this group of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 2-group parallel double blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intranasal ketamine | Active comparator | Drug: Ketamine |
| Intranasal sterile water | Placebo comparator | Drug: Sterile water |
Who may qualify
- Ages
- 12 months to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children who need to undergo procedural sedation and analgesia
Key exclusion criteria (5 listed)
- Weight over 33 Kg
- No Consent from parents/patient
- Needs immediate procedure due to patient's condition
- Growth/mental retardation
- Sensory deficit at the site of intramuscular injection
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 |
|---|---|---|
| KetamineThis is medication which is commonly used for sedation in the emergency department. At the analgesic dose, this medication can be used to reduce the pain via other routes such as intranasal. | Drug | Intranasal ketamine |
| Sterile waterIntranasal sterile water was administered via syringe. | Drug | Intranasal sterile water |
Primary outcome
Intramuscular injection pain
Time frame: immediately after Intramuscular injection
This will be assessed at the time of injection using FLACC scale.
2 secondary outcomes
Hospital stay duration
Time frame: 1 hours on average
Adverse effects
Time frame: 1 hours on average
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 2024.
- Individual participant dataSharing planned: No
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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 4 study testing Ketamine and Sterile water in people with Pain and Intranasal Ketamine, run by Tehran University of Medical Sciences at 1 site in Iran.
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 1 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 4 Jun 2024. 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 Iran. 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 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?
Intramuscular injection pain (time frame: immediately after Intramuscular injection). 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 4 Jun 2024.