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Sublingual Ketorolac Compared to Intranasal Dexmedetomidine for Postoperative Analgesia in Pediatric Patients Undergoing Bilateral Myringotomy

M

Mansoura University

Status

Withdrawn

Conditions

Elective Bilateral Myringotomy

Treatments

Drug: intranasal dexmedetomidine
Drug: sublingual ketorolac

Study type

Interventional

Funder types

Other

Identifiers

NCT03742180
R/18.06.212

Details and patient eligibility

About

The investigators aim to compare intranasal dexmedetomidine in a dose of 1ug.kg-1 with sublingual ketorolac in a dose of 1mg.kg-1 on postoperative behaviour in those children undergoing BMT during their PACU stay

Full description

Data were analyzed through SPSS (Statistical Package for Social Sciences), Program version 22. Distribution of data was first tested by Shapiro test. Data were presented as the mean and standard deviation (SD), median and range or numbers and percentages. For normally distributed data, an unpaired t-test was used to compare between mean values of both groups. For pain and sedation scores, Mann Whitney U test was used. Fisher's exact test was used for comparison of categorical data. The P value ≤ 0.05 was considered as the level of statistical significance.

A prior G power analysis was done. Using the results obtained from previous studies (14- 18) and assuming an alpha error of 0.05 and beta error 0f 0.2 (power of the study 80 %), a sample size of 60 patients per group was calculated. A drop out 10% of cases is expected, so; 33 cases per group will be required

Sex

All

Ages

2 to 7 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ASA physical status I- II.

Exclusion criteria

  • History of ketamine
  • History of NSAID
  • History of allergies
  • Any bleeding disorders
  • History of GIT bleeding
  • Those who will undergo other procedures in addition to bilateral myringotomy

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

intranasal dexmedetomidine
Experimental group
Description:
this group is planned for intranasal dexmedetomidine
Treatment:
Drug: intranasal dexmedetomidine
sublingual ketorolac
Active Comparator group
Description:
this group is planned for sublingual ketorolac
Treatment:
Drug: sublingual ketorolac

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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