An interventional study of Atropine (0.01mg/kg) and Glycopyrrolate (0.01mg/kg) in Sialorrhea, sponsored by Craig J. Huang. Completed at 1 site in United States. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2014-04-16.
Sponsored by Craig J. Huang · Not applicable, Interventional, and Supportive care
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.
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.
60 studies on the registry are indexed under Sialorrhea; 5 are open to participants now.
This study's enrollment of 52 is above the median of 31 across 44 interventional studies indexed under Sialorrhea.
Browse Sialorrhea studies →This is the only study on the registry with Craig J. Huang as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Normal saline 0.9%
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.
Drug: Atropine (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.
Drug: Glycopyrrolate (0.01mg/kg)
Drug page: Atropine
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.
Also known as: AtroPen, Atropine sulfate
Drug page: Glycopyrrolate
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.
Also known as: Robinul
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
Also known as: 0.9% Sodium Chloride
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
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
| Milestone | Placebo | Atropine | Glycopyrrolate |
|---|---|---|---|
| Started | 17 | 17 | 18 |
| Completed | 17 | 17 | 18 |
| Not completed | 0 | 0 | 0 |
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)
| ml/min | Placebo | Atropine | Glycopyrrolate |
|---|---|---|---|
| Difference in Salivary Flow Rate (ml/Min) Between Study Groups | .072 ± 0.111 | .003 ± 0.0084 | NA ± NA |
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.
| adverse events | Placebo | Atropine | Glycopyrrolate |
|---|---|---|---|
| Monitoring of Adverse Events During Study Administration | 1 | 0 | 0 |
Collected over 9 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | — | 0/17 (0%) | 1/17 (5.9%) |
| Atropine | — | 0/17 (0%) | 0/17 (0%) |
| Glycopyrrolate | — | 0/18 (0%) | 0/18 (0%) |
| Event | Placebo | Atropine | Glycopyrrolate |
|---|---|---|---|
| VomitingGastrointestinal disorders | 1/17 | 0/17 | 0/18 |
| Age, Continuous(years) | Placebo | Atropine | Glycopyrrolate | Total |
|---|---|---|---|---|
| Mean | 5.34 ± 4.07 | 5.09 ± 3.76 | 4.48 ± 3.09 | 4.85 ± 3.01 |
| Sex: Female, Male(Participants) | Placebo | Atropine | Glycopyrrolate | Total |
|---|---|---|---|---|
| Female | 6 | 8 | 11 | 25 |
| Male | 11 | 9 | 7 | 27 |
| Region of Enrollment(participants) | Placebo | Atropine | Glycopyrrolate | Total |
|---|---|---|---|---|
| United States | 17 | 17 | 18 | 52 |
The record gives a start of Jun 2010, a primary completion of Jan 2011 and a completion of Jan 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2014, 3 years 2 months after primary completion.
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This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Atropine · Glycopyrrolate