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A clinical trial to study the effectivity of two interventions,ice therapy and drug Dexmedetomidine in reducing pain caused by injection of a drug,Propofol.

Prevention of pain on injection of Propofol using Ice gel pack versus pre-treatment with Dexmedetomidine : A randomised controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/02/040189
Enrollment
274
Registered
2022-02-10
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Ice gel pack: An ice gel pack (241 x 108 mm)will be applied proximal to the intravenous cannula for a duration of 1-2 minutes(contact will be ensured by velcro tape ),then the ice gel p

Sponsors

Dr Manisha Biswal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)American system of classification category I,II,III 2)elective/emergency surgeries 3)undergoing general anesthesia

Exclusion criteria

Exclusion criteria: 1)allergy to any of the drugs being used 2)rapid sequence induction 3)anticipated difficulty in venous access 4)contra-indications to use of propofol/dexmedetomidine 5)chronic pain 6)diabetic neuropathy 7)difficulty in speech/communication 8)psychiatric illness

Design outcomes

Primary

MeasureTime frame
To compare overall incidence of pain as well as occurrence of various grades of pain after propofol injection ,following application of ice gel pack (causing local cooling) with intravenous dexmedetomidine pre-treatmentTimepoint: 10 seconds

Secondary

MeasureTime frame
compare dose of propofol needed for induction between the ice gel pack therapy group and dexmedetomidine pre-treatment groupTimepoint: 5 minutes;compare the hemodynamic changes including blood pressure and heart rate ,at the time of induction ,between the two groupsTimepoint: baseline,1 minute,2 minutes,3 minutes,4 minutes,5 minutes;incidence of discomfort to the patients on application of ice gel packTimepoint: 2 minutes

Countries

India

Contacts

Public ContactDr Manisha Biswal

PostGraduate Institute of Medical Education and Research

dr.rajeevchauhan@gmail.com7087422950

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026