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Premedication in Children: a Clinical Trial Comparing Oral Ketamine and Oral Clonidine With Respect to Sedation Level and Opioid Consumption in Pediatrics Undergoing Elective Lower Abdominal Day-case Surgery.

ConditionsPediatric SedationClonidine SedationKetamine Sedation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-12
SponsorCairo University

About this trial

Aim of the work Is to compare between oral ketamine and oral clonidine regarding the level of sedation pre and postoperatively in addition the need of opioids administration intraoperative in children undergoing elective lower abdominal day-case surgery.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Children aged between 3 to 12 years old of both sexes undergoing elective lower abdominal day-case surgery such as: oblique inguinal herniorrhaphy, hypospadias correction and circumcision.

ASA I and II

Disqualifiers

Parents refusal.

ASA risk score >II

Heart, lung, neurological, or central nervous system disorders (hypotension, hypovolemia, severe bradyarrhythmia, atrioventricular block II or III, acute cerebrovascular events, impaired consciousness, respiratory disorders with hypoventilation, myasthenia gravis and central sleep apnea syndrome)

Allergy from the used drugs.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oral Clonidine (OC)

    Drug

    compare between oral ketamine and oral clonidine regarding the level of sedation pre and postoperatively in addition the need of opioids administration intraoperative in children undergoing elective lower abdominal day-case surgery.

Treatment groups

84 Participants
are divided into 2 treatment groups
Group A: Group Oral Clonidine (OC)Active comparator 1 intervention
Group B: Group Oral Ketamine (OK)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Sedation level

using Ramsey sedation scale (RSS)

Time frame
60 minutes after administration of the drug (at time of separation from the parents).

Secondary outcomes

1

Fentanyl administration.

Need and timing of fentanyl administration intraoperatively.

Time frame
at 10, 20, 30, 40, 50 minutes until the end of the surgery
2

Postoperative emergence delirium

assessed at PACU every 15 minutes for 1 hour using pediatric anesthesia emergency and delirium scale (PAED).

Time frame
Postoperative at 15, 30, 45 and 60 minutes

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Faculty of Medicine, Cairo UniversityRecruiting Cairo, Giza GovernorateEgyptEgypt

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov
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