Postoperative Pain
Conditions
Keywords
anesthesia, analgesia, caudal, ketamine, bupivacaine
Brief summary
To find alternatives to caudal analgesia that could be more safe and effective and to demonstrate the analgesic efficacy of topical ketamine.
Detailed description
The most commonly performed inguinal surgeries in children include inguinal hernia repair with or without orchidopexy (orchiopexy). Eighty children aged 6 months to 6 yr of ASA physical status I or II, undergoing elective unilateral inguinal herniotomy will be included. In caudal group, patients will receive a mixture of 0.5 mg/ kg ketamine in 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route after anesthesia and before start of surgery. In topical group, at the end of the procedure, after identification and ligation of the hernial sac, a mixture of 0.5 mg/ kg ketamine in 0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord and upon the ilioinguinal nerve in a fan shaped manner by the surgeon. The primary outcome measure will be the time to first request for analgesia. Secondary outcome measures will include the number of analgesic doses required in the first 24 h postoperative, pain scores, sensory and motor block, agitation scores, parent satisfaction and adverse effects in the first 48h postoperative.
Interventions
DRUGKetamine
0.5 mg/ kg ketamine with bupivacaine by caudal route after anesthesia and before start of surgery.
DRUGBupivacaine
1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
6 Months to 6 Years
Healthy volunteers
No
Inclusion criteria
1. age (6 months to 6 years) 2. ASA physical status I or II. 3. Operation: elective unilateral inguinal herniotomy.
Exclusion criteria
1. A history of developmental delay or mental retardation, 2. Known or suspected coagulopathy, 3. Known allergy to any local anaesthetic, 4. Known congenital anomaly of the spine or signs of spinal anomaly, 5. Infection at the sacral region.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to first request for postoperative analgesia | 48 hours postoperative | time in hours from admission to PACU till first request for analgesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) pain score | 180 minutes postoperative | — |
| Faces Legs Activity Cry Consolability tool (FLACC, 0-10). | 180 minutes postoperative. | — |
| the agitation score (0= child is asleep, 1= awake/calm, 2= irritable/ consolable cry, 3=inconsolable cry, 4= the child is agitating and thrashing and restlessness). | 60 minutes postoperative | — |
| total consumption of postoperative analgesics | 48 hours postoperative | the amount of analgesic drugs in mg given in the first 48h postoperative |
| noninvasive blood pressure | Intra-operative | — |
| heart rate | Intra-operative | — |
| Verbal Numeric Rating Scale (VNRS) | 48 hours postoperative | the pain score will be assessed at frequent intervals in the 1st 48 h postoperative |
| parent's satisfaction on a four-point Likert scale (1, excellent; 2, good; 3, fair; 4, poor). | 48 hours postoperative | the score will be recorded once at the end of the study |
Countries
Egypt
Outcome results
None listed