SialorrheaNCT01191398
Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation
A study testing Atropine (0.01mg/kg), Glycopyrrolate (0.01mg/kg) and Normal saline 0.9% in people with Sialorrhea, run by Craig J. Huang at 1 site in United States.
Trial summary
The purpose of this study is to determine if the antisialagogues (anti-salivary agents), Atropine and Glycopyrrolate, are effective in reducing hypersalivation when sedating patients with Ketamine for procedural sedation in the emergency department or abscess clinic. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Sialorrhea
- What is being tested?
- Atropine (0.01mg/kg), Glycopyrrolate (0.01mg/kg) and Normal saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Jan 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children age 6 months to 18 years (inclusive) presenting to Children's Medical Center Emergency Department or Abscess Clinic.
- Children whom the attending physician feels need procedural sedation with the intravenous medication, Ketamine.
Who cannot join
- Children who are ASA class III or greater.
- Children with an allergy or contraindication to ketamine, atropine or glycopyrrolate.
- Inability to tolerate oral suctioning.
- Any condition or situation whereby the patient would be unable to have his/her head turned to one side.
- Patient history of vomiting or diarrhea in the last 24 hours
- Patients who have taken an anti-sialogogue within the previous 24 hours.
- Patients that need to receive Midazolam or other benzodiazepines.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Medical Center at Dallas
Dallas, Texas, 75390
About this study
The purpose of this study is to determine if the antisialagogues (anti-salivary agents), Atropine and Glycopyrrolate, are effective in reducing hypersalivation when sedating patients with Ketamine for procedural sedation in the emergency department or abscess clinic. The investigators will measure salivary flow rate by collecting oral secretions by oral suctioning over a 30 minute time period starting with the administration of Ketamine. The investigators hypothesize that patients who receive either atropine or glycopyrrolate will have fewer oral secretions than patients who receive placebo.
Read the detailed description
Ketamine is a common sedation agent used in the pediatric emergency department for a variety of procedures, used in clinical practice since 1970. One potential side effect of Ketamine is hypersalivation, potentially leading to laryngospasms. To prevent hypersalivation (and reduce the potential for laryngospasms), an anti-salivary agent, such as Atropine, is commonly given in combination with Ketamine. Recently, however, the necessity of this practice has been brought into question. The consideration of using a different drug, glycopyrrolate, has been debated. The purpose of this study is to compare the effectiveness of each medication in addition to the placebo control.
Patients enrolled into this study must present to the emergency department or abscess clinic with the need to receive Ketamine as part of a sedation procedure (as determined by the treating physician). This study will randomize enrolled patients to receive double-blinded Atropine, Glycopyrrolate or placebo given 30 minutes prior to Ketamine. After Ketamine is administered, a trained medical person will suction the patient's mouth every 5 minutes for a total of 30 minutes, collecting all oral secretions. Total saliva production will be measured and salivary flow rates will be calculated and compared between each assigned group. Adverse events and complications will be monitored throughout the patient's stay in the emergency department or abscess clinic.
- Conditions
- Sialorrhea
- Being tested
- Atropine (0.01mg/kg), Glycopyrrolate (0.01mg/kg), Normal saline 0.9%
- Keywords
- Hypersalivation, Conscious Sedation, Procedural Sedation, Ketamine, Atropine, Glycopyrrolate
- Medical subject headings
- Sialorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atropine (0.01mg/kg)Drug
Also called AtroPen, Atropine sulfate
Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
Glycopyrrolate (0.01mg/kg)Drug
Also called Robinul
Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
Normal saline 0.9%Drug
Also called 0.9% Sodium Chloride
Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine
| Study group | Role | What they receive |
|---|---|---|
| Placebo and Ketamine | Placebo comparator | Normal Saline 0.9% will act as a placebo. Two ml of normal saline 0.9% will be administered intravenously 30 minutes prior to the administration of the ketamine. Receives: Drug: Normal saline 0.9% |
| Atropine and Ketamine | Active comparator | Atropine will be administered as a single dose of 0.01 mg/kg, with a minimum of dosage of 0.1 mg and a maximum dosage of 0.4 mg, intravenously 30 minutes before the administration of the ketamine. Receives: Drug: Atropine (0.01mg/kg) |
| Glycopyrrolate and Ketamine | Active comparator | Glycopyrrolate will be administered as a single dose of 0.01 mg/kg, with no minimum dosage and a maximum dose of 0.4 mg, intravenously 30 minutes before the administration of the ketamine. Receives: Drug: Glycopyrrolate (0.01mg/kg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Salivary Flow Rate (ml/Min) Between Study Groups
Oral Secretions will be collected by oral suctioning starting at the time Ketamine is administed until 30 minutes post Ketamine administration. Suctionings will be done by trained personnel every 5 minutes starting with the Ketamine administration. Flow rate will be calculated by dividing the total volume of saliva suctioned by the total time suctioned (30 minutes)
Measured: 30 minutes
Secondary outcomes (1)
Monitoring of Adverse Events During Study Administration
Subjects will be monitored for episodes of apnea, laryngospasm, vomiting, oxygen desaturation(<92%), and changes in heart rate and blood pressure. The time frame will include the time the study medication is administered until at least 30 minutes post Ketamine administration.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SialorrheaStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig J. Huang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Craig J. Huang, University of Texas Southwestern Medical Center
- Investigators
- Adriana Rodriguez, MD, Study chair, University of Texas Southwestern Medical CenterCraig Huang, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01191398
- Sponsor's protocol ID
- 012008-058
- Status last verified
- Mar 2014
- First submitted
- 27 Aug 2010
- Last updated
- 16 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation
- ClinicalTrials.gov ID
- NCT01191398
- Acronym / sponsor ID
- 012008-058
- Conditions
- Sialorrhea
- Keywords
- Hypersalivation, Conscious Sedation, Procedural Sedation, Ketamine, Atropine, Glycopyrrolate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Craig J. HuangUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 30 Aug 2010 (estimated)
- Results
- Posted 20 Mar 2014
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 if the antisialagogues (anti-salivary agents), Atropine and Glycopyrrolate, are effective in reducing hypersalivation when sedating patients with Ketamine for procedural sedation in the emergency department or abscess clinic. The investigators will measure salivary flow rate by collecting oral secretions by oral suctioning over a 30 minute time period starting with the administration of Ketamine. The investigators hypothesize that patients who receive either atropine or glycopyrrolate will have fewer oral secretions than patients who receive placebo.
Detailed description
Ketamine is a common sedation agent used in the pediatric emergency department for a variety of procedures, used in clinical practice since 1970. One potential side effect of Ketamine is hypersalivation, potentially leading to laryngospasms. To prevent hypersalivation (and reduce the potential for laryngospasms), an anti-salivary agent, such as Atropine, is commonly given in combination with Ketamine. Recently, however, the necessity of this practice has been brought into question. The consideration of using a different drug, glycopyrrolate, has been debated. The purpose of this study is to compare the effectiveness of each medication in addition to the placebo control.
Patients enrolled into this study must present to the emergency department or abscess clinic with the need to receive Ketamine as part of a sedation procedure (as determined by the treating physician). This study will randomize enrolled patients to receive double-blinded Atropine, Glycopyrrolate or placebo given 30 minutes prior to Ketamine. After Ketamine is administered, a trained medical person will suction the patient's mouth every 5 minutes for a total of 30 minutes, collecting all oral secretions. Total saliva production will be measured and salivary flow rates will be calculated and compared between each assigned group. Adverse events and complications will be monitored throughout the patient's stay in the emergency department or abscess clinic.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo and Ketamine | Placebo comparator | Drug: Normal saline 0.9%Normal Saline 0.9% will act as a placebo. Two ml of normal saline 0.9% will be administered intravenously 30 minutes prior to the administration of the ketamine. |
| Atropine and Ketamine | Active comparator | Drug: Atropine (0.01mg/kg)Atropine will be administered as a single dose of 0.01 mg/kg, with a minimum of dosage of 0.1 mg and a maximum dosage of 0.4 mg, intravenously 30 minutes before the administration of the ketamine. |
| Glycopyrrolate and Ketamine | Active comparator | Drug: Glycopyrrolate (0.01mg/kg)Glycopyrrolate will be administered as a single dose of 0.01 mg/kg, with no minimum dosage and a maximum dose of 0.4 mg, intravenously 30 minutes before the administration of the ketamine. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children age 6 months to 18 years (inclusive) presenting to Children's Medical Center Emergency Department or Abscess Clinic.
- Children whom the attending physician feels need procedural sedation with the intravenous medication, Ketamine.
Key exclusion criteria (7 listed)
- Children who are ASA class III or greater.
- Children with an allergy or contraindication to ketamine, atropine or glycopyrrolate.
- Inability to tolerate oral suctioning.
- Any condition or situation whereby the patient would be unable to have his/her head turned to one side.
- Patient history of vomiting or diarrhea in the last 24 hours
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 |
|---|---|---|
| Atropine (0.01mg/kg)Also: AtroPen, Atropine sulfateAtropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine. | Drug | Atropine and Ketamine |
| Glycopyrrolate (0.01mg/kg)Also: RobinulGlycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine. | Drug | Glycopyrrolate and Ketamine |
| Normal saline 0.9%Also: 0.9% Sodium ChlorideNormal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine | Drug | Placebo and Ketamine |
Primary outcome
Difference in Salivary Flow Rate (ml/Min) Between Study Groups
Time frame: 30 minutes
Oral Secretions will be collected by oral suctioning starting at the time Ketamine is administed until 30 minutes post Ketamine administration. Suctionings will be done by trained personnel every 5 minutes starting with the Ketamine administration. Flow rate will be calculated by dividing the total volume of saliva suctioned by the total time suctioned (30 minutes)
1 secondary outcome
Monitoring of Adverse Events During Study Administration
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Adriana Rodriguez, MD study chair
University of Texas Southwestern Medical Center
Craig Huang, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atropine (0.01mg/kg), Glycopyrrolate (0.01mg/kg) and Normal saline 0.9% in people with Sialorrhea, run by Craig J. Huang at 1 site in United States.
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 2 inclusion and 7 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 16 Apr 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Difference in Salivary Flow Rate (ml/Min) Between Study Groups (time frame: 30 minutes). 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 16 Apr 2014.