Effectiveness of Atropine and Glycopyrrolate to Reduce Hyper Salivation With Ketamine Sedation
Condition: Sialorrhea
MeSH terms: Sialorrhea
Study type: Interventional

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.
    

Intervention name(s): Atropine (0.01mg/kg); Glycopyrrolate (0.01mg/kg); Normal saline 0.9%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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 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 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
Other intervention name(s): AtroPen; Atropine sulfate; Robinul; 0.9% Sodium Chloride
Intervention MeSH terms: Atropine; Glycopyrrolate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Hypersalivation; Conscious Sedation; Procedural Sedation; Ketamine; Atropine; Glycopyrrolate