Sub-dissociative Intranasal Ketamine for Pediatric Sickle Cell Pain Crises

Brief Summary

The purpose of this study is to determine if the use of ketamine, sniffed in the nose, is a safe and effective way to help reduce pain in pediatric sickle cell patients with pain crises in resource-limited settings.

Intervention / Treatment

  • Drug: Ketamine
  • Drug: Normal saline
  • Other: Standard Pain Therapy
  • Other: Pediatric Quality of Life - Sickle Cell Disease Module
  • Other: Faces Pain Scale - Revised

Condition or Disease

  • Sickle Cell Disease

Phase

Study Design

Study type: Interventional
Status: Recruiting
Study results: No Results Available
Age: 4 Years to 16 Years   (Child)
Enrollment: 160 ()
Funded by: Other

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Clinical Trial Dates

Start date: Dec 15, 2020
Primary Completion: Jul 19, 2020
Completion Date: Jul 19, 2020
Study First Posted: Oct 12, 2015
Results First Posted: Aug 31, 2020
Last Updated: Mar 14, 2019

Sponsors / Collaborators

Lead Sponsor: N/A
Responsible Party: N/A

This is a randomized, placebo-controlled, drug trial using sub-dissociative intranasal ketamine as an adjunct to standard pharmacotherapy for the management of pediatric sickle cell disease vasoocclusive pain crises in resource-poor settings. Pediatric patients will be enrolled at a teaching and referral hospital in West Africa. Patients will be randomly assigned to the treatment arm - standard therapy plus sub-dissociative intranasal ketamine (1 mg/kg) given at time zero) or the control arm - standard therapy plus intranasal normal saline (volume-matched to treatment arm), and patients will evaluated at standard intervals to assess for pain scores and vital signs (0 minutes, 30 minutes, 60 minutes, and 120 minutes). Pain will be assessed using the Faces Pain Scale - Revised (FPS-R). Patients will also be observed for any potential side effects or adverse events. All patients will be contacted 2-3 weeks post intranasal medication administration for over-the-phone follow-up using a portion of the PedsQL-SCD questionnaire, to assess for basic quality of life related to pain management and treatment.

Eligibility Criteria

Sex: All
Minimum Age: 4
Maximum Age: 16

This clinical trial is recruiting

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More Details

NCT Number: NCT02573714
Other IDs: IRB2015-07|MNH/IRB/I/2015/14|TFDA0015/CTR/0015/9|NIMR/HQ/R.8a/Vol. IX/2299
Study URL: https://ClinicalTrials.gov/show/NCT02573714
Last updated: Mar 18, 2021