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Children of Age 2-6years Undergoing Elective Surgery Will be Divided Into Two Groups Randomly. This Study Aims to Evaluate if Intranasal Dexmedetomidine is Better Than Intranasal Ketamine in Producing Sedation and Reducing Parent Separation Anxiety Before Surgery.

ConditionsSedationPreoperative Anxiety Experienced by the Pediatric PatientAnxiolytic EffectSedation and Analgesia
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age2-6
SponsorLiaquat National Hospital & Medical College

About this trial

This study aims to compare intranasal dexmedetomidine versus intranasal ketamine as a premedication in children undergoing surgery in our population. Hypothesis is Intranal dexmedetomidine is better than intranasal ketamine in producing preoperative sedation in pediatric patients undergoing surgery under general anesthesia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American society of Anesthesiologist (ASA) class-I and II

Children 2-6 years of age undergoing elective surgery

Disqualifiers

Known hypersensitivity to study drugs

Refusal of consent

Known renal, hepatic or cardiac dysfunction

Nasal deformity or pathology

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intranasal dexmedetomidine

    Drug

    intranasal dexmedetomidine 2mcg/kg

  • Intranasal ketamine

    Drug

    intranasal ketamine 2mg/kg

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intranasal DexmedetomidineActive comparator 1 intervention
Group B: Intranasal ketamineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Sedation score as assessed by MOAA/S

Modified Observer's Assessment of Alertness/ Sedation scale (MOAA/S): 6 = Appears alert and awake, responds readily to name spoken in a normal tone 5 = Appears asleep but responds readily to name spoken in a normal tone 4 = Lethargic response to name spoken in a normal tone 3 = Responds only after the name is called loudly or repeatedly 2 = Responds only after mild prodding or shaking 1 = Does not respond to mild prodding or shaking

Time frame
6 months

Secondary outcomes

1

Ease of parental separation using PSAS

Parental Separation Anxiety Score (PSAS): 1. = Excellent (unafraid, cooperative) 2. = Good (slight fear or crying, easily reassured) 3. = Fair (moderate fear, not quiet with reassurance) 4. = Poor (crying, needing restraint)

Time frame
6 months
2

Incidence of hypotension and bradycardia in the two groups

Intraoperative hypotension and bradycardia will be monitored before induction then every 5 minutes till the end of surgery or a maximum of 1 hour in the operating room.

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Liaquat National Hospital & Medical College

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: