Trial Outcomes & Findings for Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally (NCT NCT01380197)

Results Overview

Number of Participants with Acute Chest Syndrome or A new pulmonry infiltrate on Chest X-ray

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

40 participants

Primary outcome timeframe

3 days

Results posted on

2018-02-20

Participant Flow

Participant milestones

Participant milestones
Measure	Randomizing Particiipants to Morphine Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled. Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).	Randomization to Nubain Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled. Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Choosing Opioid Management for Pain and Analyzing Acute Chest Syndrome (ACS) Rates Equally

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomizing Particiipants to Morphine n=20 Participants Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled. Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).	Randomization to Nubain n=20 Participants Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled. Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	7 Participants n=7 Participants	19 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 days

Number of Participants with Acute Chest Syndrome or A new pulmonry infiltrate on Chest X-ray

Outcome measures

Outcome measures
Measure	Randomizing Particiipants to Morphine n=20 Participants Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled. Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).	Randomization to Nubain n=20 Participants Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled. Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).
Acute Chest Syndrome	2 participants	1 participants

SECONDARY outcome

Timeframe: 2 days

Outcome measures

Outcome measures
Measure	Randomizing Particiipants to Morphine n=20 Participants Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled. Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).	Randomization to Nubain n=20 Participants Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled. Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs).
Number of Participants Who Experienced Pain Relief	2 participants	2 participants

Adverse Events

Randomizing Particiipants to Morphine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Randomization to Nubain

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Iris Buchanan

Morehouse School of Medicine

Phone: 404-398-9578

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place