Effect of Fentanyl on Emergence Delirium (ED) on Children Undergoing Adeno-tonsilectomy at Kenyatta National Hospital (KNH)

NCT ID: NCT02753725

Last Updated: 2016-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-07-31

Brief Summary

This study will be a randomized double blind placebo controlled clinical trial among children undergoing adeno-tonsillectomy in KNH. The intervention arm will comprise Fentanyl given at a dose of 1ug/while the placebo arm will be given normal saline at a volume equivalent to Fentanyl dose, treatment will be administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed. The main outcome will be incidence of ED at the recovery room using Watcha scale and secondary outcomes will be delay in emergence time from anaesthesia and effectiveness of fentanyl in preventing ED.

Conditions

Emergence Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Fentanyl group

Fentanyl given at a dose of one micro gram per kilogram body weight

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: DRUG

The intervention arm will comprise Fentanyl given at a dose of one microgram per kilogramme body weight administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed.

normal saline group

placebo arm will be given normal saline at a volume equivalent to Fentanyl dose as per body weight.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

the placebo arm will be given normal saline at a volume equivalent to Fentanyl dose per body weight,administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed

Interventions

Fentanyl

The intervention arm will comprise Fentanyl given at a dose of one microgram per kilogramme body weight administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed.

Intervention Type: DRUG

Normal saline

the placebo arm will be given normal saline at a volume equivalent to Fentanyl dose per body weight,administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed

Intervention Type: DRUG

Other Intervention Names

treatment; placebo

Eligibility Criteria

Inclusion Criteria

• American Society of Anaesthesiologists classes (ASA) 1 and 2 children.

• ASA 1 - Normal healthy child scheduled for adeno-tonsilectomy.
• ASA 2 - Child with mild systemic disease without functional limitations.
• Children aged 1 to 12 years.
• Children undergoing elective adeno-tonsilectomy.
• Those children whose parents/guardians have given a written informed consent.

Exclusion Criteria

• Children with genetic syndromes.
• Children with psychological/neurological behavioural disorders.
• Children with allergies to Fentanyl.
• Children with psychiatric disorders/ use of psychiatric medications.
• Use of sedative medications one hour prior to surgery.
• Children with developmental delay.
• Children coming in as day case.
• Children with airway problems not related to the surgery-sleep apnoea.
• Children less than 1 year and those above 13 years.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nairobi

OTHER

Sponsor Role: lead

Responsible Party

Dr. Kirwa Elisha kiprono

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

UNairobi 1

Identifier Type: -

Identifier Source: org_study_id