Postoperative Analgesia Clinical Trial
Official title:
Analgo-Sedative Effects Of Oral, Or Nebulized Ketamine In Pre-schoolers Undergoing Elective Surgery: A-Comparative Randomized Double Blind Study
Verified date | June 2019 |
Source | Zagazig University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
the primary objective of this study is to investigate the sedative, and analgesic effects of oral, or nebulized ketamine as premedication drugs, and providing postoperative analgesia for the preschoolers and decrease their need for systemic analgesia.The secondary objective is to compare each sedation technique after oral, or nebulized ketamine for safety ,and procedural outcomes.
Status | Completed |
Enrollment | 62 |
Est. completion date | June 1, 2019 |
Est. primary completion date | May 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 3 Years to 6 Years |
Eligibility |
Inclusion Criteria: - Parents acceptance. - Age (3-6) years old. - American Society of Anesthesiologist physical status (ASA) I / II - Elective surgery of approximately half to one hour duration under general anesthesia. - Child With Body Mass Index (BMI) (15-18kg/m²) Exclusion Criteria: - Parents refusal. - Altered mental status, and epilepsy. - History of allergy to ketamine. - Recent respiratory tract infection. - Sever dysfunction of the central nervous system. - Increased intracranial pressure, and increased intra-ocular pressure. - Cardiac dysrhythmia ,and/or congenital heart disease. |
Country | Name | City | State |
---|---|---|---|
Egypt | Zagazig University Hospitsals | Zagazig |
Lead Sponsor | Collaborator |
---|---|
Zagazig University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | evaluate sedative effects of oral, or nebulized ketamine in preschoolers undergoing elective surgery | • To assess onset time of sedation by sedation scale (SS-5) score. The sedation scale: Rarely awake, needs shaking, or shouting to wake up. Asleep, eyes closed, wake up when called softly,or lightly touched. Sleepy, but eyes open spontaneously. Awake. Agitated. |
30 minutes. | |
Primary | compare each sedation technique for the time of separation state. | The separation state will be assessed and designated as satisfactory separation if the Emotional State Scale (ESS-4) score will be no more than two points. The Emotional State Scale (ESS-4): Calm. Apprehensive, not smiling, tentative behavior, withdrawn. Crying. Thrashing, crying with movements of the arms, and legs, resisting. |
at 30 minutes after drug intake | |
Primary | compare the sedation technique for successful venous cannulation. | Successful venous cannulation is defined as an Emotional State Scale (ESS-4= 2). The Emotional State Scale (ESS-4): Calm. Apprehensive, not smiling, tentative behavior, withdrawn. Crying. Thrashing, crying with movements of the arms, and legs, resisting. |
at time of attempted cannulation, regardless of whether the vein is actually cannulated on the first attempt. | |
Secondary | to compare the intensity of pain postoperative. | the intensity of pain will be assessed using modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS). Score 1 2 3 Cry No cry Crying, moaning Scream Facial Smiling Composed Grimace Verbal Positive None, or other complaints Pain complaint Torso Neutral Shifting, tense, upright Restrained Leg Neutral kicks, squirm, drawn up Restrained Touch No touching Reach, touch, grab Restrained CHEOPS pain score=SUM(0)(points for all 6 parameters). Interpretation : minimum score:6, maximum score:18. |
immediately after recovery, and every half hour for four hours postoperative |
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