Efficacy of Dexmedetomidine for Postoperative Analgesia in Infantile Cataract Surgery

Postoperative Pain Clinical Trial

Official title:

Subtenon Versus Intravenous Dexmedetomidine for Postoperative Analgesia and Vomiting Control in Infantile Cataract Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02495220
• Other study ID #: IRB00008711068
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 3, 2015
• Last updated: January 26, 2017
• Start date: July 2015
• Est. completion date: November 2017

Study information

• Verified date: January 2017
• Source: Assiut University
• Contact: jehan A sayed, MD
• Phone: +2 01006253939
• Email: jehan.alloul[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the present study was to evaluate the efficacy and safety of subtenon block (SB)anesthesia with dexmedetomidine in combination with bupivacaine versus intravenous dexmedetomidine for postoperative analgesia and emesis control in infants undergoing cataract surgery.

Description:

In this prospective, randomized, controlled, double blind trial eighty ASA physical status grade I and II infants (1-12month) undergoing elective cataract surgery in one eye under general anesthesia were studied. Infants were randomly allocated to one of the two groups: subtenon block Group (SB) with dexmedetomidine (n =40) or intravenous dexmedetomidine Group (IV) (n =40). After securing the airway, infants in Group (SB) received SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture, whereas infants in Group (IV) received 1µ/kg IV dexmedetomidine after induction of anesthesia. Surgery started after 5 min of study drug administration. Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics was the primary outcome. CRIES pain scale score , vomiting scale score during4-h study period, incidence of oculocardiac reflex and any surgical difficulty were the Secondary outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 12 Months

Eligibility

Inclusion Criteria:

1. ASA physical status grade I and II infants (1-12month).

2. undergoing elective cataract surgery in one eye under general anesthesia.

Exclusion Criteria:

1. infection of the orbit,

2. increased intraocular pressure(IOP),

3. history of allergy to local anesthetics,

4. history of previous eye surgery,

5. cardiovascular or clotting disorders,

6. full stomach,inner ear disorders or other conditions predisposing to vomiting

7. airway abnormalities

8. compromised sclera.

Related Conditions & MeSH terms

• Cataract
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Postoperative Vomiting
• Vomiting

Intervention

Drug:
• SB dexmedetomidine bupivacaine block
SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture
• intravenous dexmedetomidine
received 1µ/kg IV dexmedetomidine

Locations

Country	Name	City	State
Egypt	Assiut Univeristy Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative assessment for number of infants requiring rescue analgesia and rescue antiemetics	by analysis for number of infants withCRIES pain scale score >3	4 hours postoperatively
Primary	postoperative CRIES pain scale score	(0-2 for each parameter)	4 hours postoperatively
Secondary	vomiting scale score	a numeric rank score, where 0= no vomiting 1=vomited once and 2=vomited twice or more	4 hours postoperative
Secondary	Number of oculocardiac reflex(OCR)events(acute reduction in heart rate of >20%).	by analysis	intraoperative period