Topical Ketamine Versus Caudal Ketamine for Postoperative Analgesia in Children Undergoing Inguinal Herniotomy

Postoperative Pain Clinical Trial

— TKversusCK  

Official title:

Caudal Epidural Block Versus Topical Ketamine Application for Postoperative Pain Relief After Elective Inguinal Herniotomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02462174
• Other study ID #: IRB00008718/ NF
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 29, 2015
• Last updated: October 1, 2015
• Start date: May 2015
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

To find alternatives to caudal analgesia that could be more safe and effective and to demonstrate the analgesic efficacy of topical ketamine.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 6 Months to 6 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ketamine
0.5 mg/ kg ketamine with bupivacaine by caudal route after anesthesia and before start of surgery.
• Ketamine
0.5 mg/ kg ketamine with bupivacaine will be sprayed around the spermatic cord before wound closure.
• Bupivacaine
1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route
• Bupivacaine
0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord before wound closure

Locations

Country	Name	City	State
Egypt	Assiut university hospitals	Assiut	Assiut governorate

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to first request for postoperative analgesia	time in hours from admission to PACU till first request for analgesia	48 hours postoperative	No
Secondary	total consumption of postoperative analgesics	the amount of analgesic drugs in mg given in the first 48h postoperative	48 hours postoperative	No
Secondary	The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) pain score		180 minutes postoperative	No
Secondary	Faces Legs Activity Cry Consolability tool (FLACC, 0-10).		180 minutes postoperative.	No
Secondary	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	Yes
Secondary	parent's satisfaction on a four-point Likert scale (1, excellent; 2, good; 3, fair; 4, poor).	the score will be recorded once at the end of the study	48 hours postoperative	No
Secondary	noninvasive blood pressure		Intra-operative	Yes
Secondary	heart rate		Intra-operative	Yes
Secondary	Verbal Numeric Rating Scale (VNRS)	the pain score will be assessed at frequent intervals in the 1st 48 h postoperative	48 hours postoperative	No