PainPhase 4NCT01168492
Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation
A Phase 4 study testing ketamine in people with Pain, run by Université de Montréal at 1 site in Canada.
Trial summary
The purpose of this study is to determine whether ketamine, midazolam, and meperidine are more effective than midazolam and meperidine alone for procedural sedation and analgesia in pediatric digestive endoscopy. Secondary outcomes are the incidence of cardiorespiratory side effects and the necessity of rescue doses. Read more about this study
- Who is it for?
- Ages 10 to 19 years
- Conditions the study is for
- Pain
- What is being tested?
- ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2010to Jul 2013
- 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 10 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children =/> 10 years of age
- Undergoing elective diagnostic colonoscopy
- ASA score class 1-3.
Who cannot join
- Children younger than 10 years of age
- Known epilepsy under treatment
- ASA score class 4 or more
- Interventional colonoscopy (e.g.polypectomy)
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether ketamine, midazolam, and meperidine are more effective than midazolam and meperidine alone for procedural sedation and analgesia in pediatric digestive endoscopy. Secondary outcomes are the incidence of cardiorespiratory side effects and the necessity of rescue doses.
Read the detailed description
90 patients will be included. The sedation will include 0.1mg/kg, max 5mg iv of midazolam, 1mg/kg, max 50mg iv of meperidine, and placebo (0.9%NaCl) or ketamine 0.5mg/kg iv. Rescue doses will be given as usual, using meperidine and or midazolam 50% of the initial dose.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ketamineDrug
Also called no other names
0.5mg/kg ketamine iv
| Study group | Role | What they receive |
|---|---|---|
| ketamine | Experimental | group with triple sedation (ketamine, midazolam, meperidine) Receives: Drug: ketamine |
| placebo | Placebo comparator | group with conventional sedation and placebo ( midazolam, meperidine and placebo) Receives: Drug: ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
pain scores are accorded at the end of each endoscopy. Pain scores of the two groups will be compared after one year
Measured: after one year
Secondary outcomes (1)
necessity of cardiopulmonary intervention (Oxygen requirements)
according to Observer'sAssessment of Alertness/Sedation (OAAS) score
Measured: after one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Montréal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denise Herzog, Université de Montréal
- Investigators
- Denise Herzog, MD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01168492
- Sponsor's protocol ID
- cme#2857
- Status last verified
- Dec 2014
- First submitted
- 21 Jul 2010
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gilger MA, Spearman RS, Dietrich CL, Spearman G, Wilsey MJ Jr, Zayat MN. Safety and effectiveness of ketamine as a sedative agent for pediatric GI endoscopy. Gastrointest Endosc. 2004 May;59(6):659-63. doi: 10.1016/s0016-5107(04)00180-4.
PubMed 15114309McQuaid KR, Laine L. A systematic review and meta-analysis of randomized, controlled trials of moderate sedation for routine endoscopic procedures. Gastrointest Endosc. 2008 May;67(6):910-23. doi: 10.1016/j.gie.2007.12.046.
PubMed 18440381
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia During Pediatric Digestive Endoscopy: a Comparison of Two Protocols for Procedural Sedation
- ClinicalTrials.gov ID
- NCT01168492
- Acronym / sponsor ID
- cme#2857
- Conditions
- Pain
- Keywords
- pediatric, gastroscopy, colonoscopy, sedation, ketamine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Université de MontréalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 23 Jul 2010 (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 determine whether ketamine, midazolam, and meperidine are more effective than midazolam and meperidine alone for procedural sedation and analgesia in pediatric digestive endoscopy. Secondary outcomes are the incidence of cardiorespiratory side effects and the necessity of rescue doses.
Detailed description
90 patients will be included. The sedation will include 0.1mg/kg, max 5mg iv of midazolam, 1mg/kg, max 50mg iv of meperidine, and placebo (0.9%NaCl) or ketamine 0.5mg/kg iv. Rescue doses will be given as usual, using meperidine and or midazolam 50% of the initial dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine | Experimental | Drug: ketaminegroup with triple sedation (ketamine, midazolam, meperidine) |
| placebo | Placebo comparator | Drug: ketaminegroup with conventional sedation and placebo ( midazolam, meperidine and placebo) |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children =/> 10 years of age
- Undergoing elective diagnostic colonoscopy
- ASA score class 1-3.
Key exclusion criteria (4 listed)
- Children younger than 10 years of age
- Known epilepsy under treatment
- ASA score class 4 or more
- Interventional colonoscopy (e.g.polypectomy)
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: no other names0.5mg/kg ketamine iv | Drug | ketamine, placebo |
Primary outcome
pain score
Time frame: after one year
pain scores are accorded at the end of each endoscopy. Pain scores of the two groups will be compared after one year
1 secondary outcome
necessity of cardiopulmonary intervention (Oxygen requirements)
Time frame: after one year
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 Dec 2014.
- Background: PubMed 15114309Gilger MA, Spearman RS, Dietrich CL, Spearman G, Wilsey MJ Jr, Zayat MN. Safety and effectiveness of ketamine as a sedative agent for pediatric GI endoscopy. Gastrointest Endosc. 2004 May;59(6):659-63. doi: 10.1016/s0016-5107(04)00180-4.
- Background: PubMed 18440381McQuaid KR, Laine L. A systematic review and meta-analysis of randomized, controlled trials of moderate sedation for routine endoscopic procedures. Gastrointest Endosc. 2008 May;67(6):910-23. doi: 10.1016/j.gie.2007.12.046.
- research center of Sainte Justine HospitalLink provided by the sponsor.
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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.
Denise Herzog, MD principal investigator
Université de Montréal
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 in people with Pain, run by Université de Montréal at 1 site in Canada.
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 4 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 Dec 2014. 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 Canada. 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?
pain score (time frame: after one year). 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 NCT01168492, which also lists 2 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 Dec 2014.