Sialorrhea
Conditions
Keywords
Hypersalivation, Conscious Sedation, Procedural Sedation, Ketamine, Atropine, Glycopyrrolate
Brief 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. 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.
Interventions
DRUGAtropine (0.01mg/kg)
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.
DRUGGlycopyrrolate (0.01mg/kg)
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.
DRUGNormal saline 0.9%
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
Sponsors
Craig J. Huang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Salivary Flow Rate (ml/Min) Between Study Groups | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monitoring of Adverse Events During Study Administration | 1 hour | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Normal Saline0.9% will act as a placebo.
Placebo: 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 | 17 |
| Atropine Atropine (0.01mg/kg): 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. | 17 |
| Glycopyrrolate Glycopyrrolate (0.01mg/kg): 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. | 18 |
| Total | 52 |
Baseline characteristics
| Characteristic | Atropine | Placebo | Glycopyrrolate | Total |
|---|---|---|---|---|
| Age, Continuous | 5.09 years STANDARD_DEVIATION 3.76 | 5.34 years STANDARD_DEVIATION 4.07 | 4.48 years STANDARD_DEVIATION 3.09 | 4.85 years STANDARD_DEVIATION 3.01 |
| Region of Enrollment United States | 17 participants | 17 participants | 18 participants | 52 participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 11 Participants | 25 Participants |
| Sex: Female, Male Male | 9 Participants | 11 Participants | 7 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 17 | 0 / 17 | 0 / 18 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 | 0 / 18 |
Outcome results
Primary
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)
Time frame: 30 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Difference in Salivary Flow Rate (ml/Min) Between Study Groups | .072 ml/min | Standard Deviation 0.111 |
| Atropine | Difference in Salivary Flow Rate (ml/Min) Between Study Groups | .003 ml/min | Standard Deviation 0.0084 |
| Glycopyrrolate | Difference in Salivary Flow Rate (ml/Min) Between Study Groups | NA ml/min | — |
Secondary
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.
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Monitoring of Adverse Events During Study Administration | 1 adverse events |
| Atropine | Monitoring of Adverse Events During Study Administration | 0 adverse events |
| Glycopyrrolate | Monitoring of Adverse Events During Study Administration | 0 adverse events |