Postoperative Pain
Conditions
Brief summary
The aim of this study is to evaluate the analgesia efficacy of local ketamine given by two different doses in pediatric patients undergoing tonsillectomy operations
Detailed description
In this double-blinded, clinically-controlled trial, 100 child will be randomized into four groups of 25 patients each; control group, intravenous ketamine group received 0.5mg iv. ketamine, and two local ketamine groups receiving local ketamine by nebulization in two different doses; 1 and 2mg/kg. The verbal rating pain scale, time to first postoperative analgesic request, total analgesic consumption during 1st 24 h postoperative, serum ketamine levels, intra operative blood loss, postoperative bleeding, and adverse effects were evaluated.
Interventions
DRUGIntravenous ketamine0.5mg/kg
Intravenous ketamine 0.5mg/kg after anesthesia and before surgery.
DRUGNebulized Ketamine 1mg/kg
Nebulized Ketamine 1mg/kg given by nebulizer before anesthesia.
DRUGNebulized Ketamine 2mg/kg
Nebulized Ketamine 2mg/kg given by nebulizer before anesthesia.
DRUGsaline placebo
Saline 0.9% given by nebulizer before anesthesia and iv after anesthesia and before surgery.
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* ASA physical status I-II patients aged 7-12 years and scheduled for elective tonsillectomy due to recurrent or chronic tonsillitis will be included in the study
Exclusion criteria
* patients with known hypersensitivity to medication drugs, coagulation disorders, thrombocytopenia, and significant cardiac, renal, pulmonary or hepatic disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative analgesic consumption | 24 hours postoperative | The total amount of analgesics used in the first 24h postoperative in mg. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain scores | 24 hours postoperative | Pain intensity will be assessed postoperatively by using the Verbal Rating scale (VRS) (0 =no pain, 1 =mild pain, 2 =moderate pain, 3 =severe pain, and lastly 4 =excruciating pain). VRS assessments were performed at rest in the following time points; at arrival to PACU, 30 min, 1, 2, 3, 4, 5, 6, 12, and 24 h postoperative. \- \- . |
| Ketamine serum levels to exclude systemic absorption of topical ketamine. | 120 min after receiving Ketamine | the level of ketamine in the serum. |
Countries
Egypt
Outcome results
None listed