Trial · NCT01954927

Pain Management in Children and Young Adults With Sickle Cell Disease

NCT01954927, Phase 2, Completed, St. Jude Children's Research Hospital; results first posted 2019-04-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Pain Management in Children and Young Adults With Sickle Cell Disease. Trials, record NCT01954927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01954927

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Pain Management in Children and Young Adults With Sickle Cell Disease
NCT number: NCT01954927
Status: Completed
Phases: Phase 2
Enrollment: 90 participants, actual
Lead sponsor: St. Jude Children's Research Hospital
Conditions: Sickle Cell Disease
Interventions: Gabapentin, Placebo
First posted: 2013-10-07
Last updated: 2019-04-02
Results first posted: 2019-04-02

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Successful Pain Interventions by Arm Between Presentation and 3 Hours Post Administration of Study Drug	Baseline and 3 hours (±30 minutes) post administration of study drug. The 3-hour pain assessment time-period was extended for subjects that were sleep until the first available measurement.	Pain scales used are the numerical rating system, the Faces Pain Scale, and the Faces, Legs, Arms, Cry and Consolability (FLACC) pain scale (for patients 7 years or older, ages 4-6 years, or less than 4 years, respectively). For each patient, if the reduction of the pain scores (0=no pain and 10=worst possible pain) between presentation to the acute care setting and 3 hours post administration of study drug is 33% or greater, then this patient will be defined as having a successful intervention. The proportions of successful interventions in the gabapentin and placebo groups will be estimated and compared using Z-test.
Secondary	Morphine Equivalent Doses Administered From Presentation to 3-hours Post Treatment With Gabapentin/Placebo	The 3-hour pain assessment was the pain assessment closest in time to the 3-hour time and was typically within 30 minutes of target. The time period was extended for 12 patients that were sleeping.	The equivalent dose of morphine in mg
Other	Number of Participants With Successful Pain Interventions by Arm Between Presentation and Point of Decision for Either Hospital Admission or Discharge to Home	From time of presentation to the acute care setting until time of either discharge to home or admission to the hospital, up to 8 hours.	For each patient, if the reduction of the pain scores (0=no pain and 10=worst possible pain) between presentation to the acute care setting and Point of decision for either hospital admission or discharge to home is 33% or greater, then this patient will be defined as having a successful intervention.
Other	Morphine Equivalent Doses Administered From Presentation to the Point of Decision for Either Admission or Discharge to Home	From time of presentation to the acute care setting until time of either discharge to home or admission to the hospital, up to 8 hours.	To compare the total morphine equivalent dose (mg/kg) used to control pain during VOC between presentation to the acute care setting and the point of decision for either admission or discharge to home, in the gabapentin and placebo groups.
Other	Hospital Admission	From time of presentation to the acute care setting until time of either discharge to home or admission to the hospital, up to 8 hours.	To compare the rate of admission related to pain management, in the gabapentin vs. placebo groups. (Outcome: binary response - admitted or discharged)
Other	Absolute Change in Pain From Study Drug to 3 Hours Post Administration of Study Drug	Study drug administration to 3-hours post study drug administration	To compare the change in pain score from time of administration of study drug to assessment at 3 hours post administration of study drug in the gabapentin vs. placebo groups. (0=no pain and 10=worst possible pain)
Other	Absolute Change in Pain, Study Drug to Hospital Discharge Decision	From time of presentation to the acute care setting until time of either discharge to home or admission to the hospital, up to 8 hours.	To compare the change in pain score from time of administration of study drug to the point of decision for either admission or discharge to home, in the gabapentin and placebo groups. (0=no pain and 10=worst possible pain)

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With Successful Pain Interventions by Arm Between Presentation and 3 Hours Post Administration of Study Drug	Baseline and 3 hours (±30 minutes) post administration of study drug. The 3-hour pain assessment time-period was extended for subjects that were sleep until the first available measurement.	Patients with Sickle cell disease (any genotype) ages ≥1 year and \<21 years seeking care for acute vaso-occlusive pain at St Jude Children's Hospital. A total of 4 subjects were missing the pain assessment at 3 hours (2 in each arm). The resulting sample sizes were n=40 (Gabapentin arm) and n=42 (placebo arm), for a total sample size of n=82.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Morphine Equivalent Doses Administered From Presentation to 3-hours Post Treatment With Gabapentin/Placebo	The 3-hour pain assessment was the pain assessment closest in time to the 3-hour time and was typically within 30 minutes of target. The time period was extended for 12 patients that were sleeping.	Patients with Sickle cell disease (any genotype) ages ≥1 year and \<21 years seeking care for acute vaso-occlusive pain at St Jude Children's Hospital.	mg/kg	MEDIAN
OTHER_PRE_SPECIFIED	Number of Participants With Successful Pain Interventions by Arm Between Presentation and Point of Decision for Either Hospital Admission or Discharge to Home	From time of presentation to the acute care setting until time of either discharge to home or admission to the hospital, up to 8 hours.	Patients with Sickle cell disease (any genotype) ages ≥1 year and \<21 years seeking care for acute vaso-occlusive pain at St Jude Children's Hospital. There were 2 subjects in the Gabapentin group that did not have a pain assessment admit/discharge decision. N=84 patients had assessments at both presentation and admit/discharge.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Morphine Equivalent Doses Administered From Presentation to the Point of Decision for Either Admission or Discharge to Home	From time of presentation to the acute care setting until time of either discharge to home or admission to the hospital, up to 8 hours.	Patients with Sickle cell disease (any genotype) ages ≥1 year and \<21 years seeking care for acute vaso-occlusive pain at St Jude Children's Hospital.	mg/kg	MEDIAN
OTHER_PRE_SPECIFIED	Hospital Admission	From time of presentation to the acute care setting until time of either discharge to home or admission to the hospital, up to 8 hours.	Patients with Sickle cell disease (any genotype) ages ≥1 year and \<21 years seeking care for acute vaso-occlusive pain at St Jude Children's Hospital.	Participants	COUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIED	Absolute Change in Pain From Study Drug to 3 Hours Post Administration of Study Drug	Study drug administration to 3-hours post study drug administration	Patients with Sickle cell disease (any genotype) ages ≥1 year and \<21 years seeking care for acute vaso-occlusive pain at St Jude Children's Hospital. Placebo arm: 6 subjects missed pain assessments at treatment; 2 missed pain assessment at 3h. Gabapentin arm: 7 missed pain assessment at treatment; 2 of the 7 also missed the assessment at 3h.	score on a scale	MEDIAN
OTHER_PRE_SPECIFIED	Absolute Change in Pain, Study Drug to Hospital Discharge Decision	From time of presentation to the acute care setting until time of either discharge to home or admission to the hospital, up to 8 hours.	Patients with Sickle cell disease (any genotype) ages ≥1 year and \<21 years seeking care for acute vaso-occlusive pain at St Jude Children's Hospital. Placebo arm: 6 subjects missed pain assessments at treatment. Gabapentin arm: 7 subjects missed pain assessment at treatment; 2 of the 7 missed the assessment at hospital discharge decision.	score on a scale	MEDIAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With Successful Pain Interventions by Arm Between Presentation and 3 Hours Post Administration of Study Drug	Gabapentin	No	13		Participants
Number of Participants With Successful Pain Interventions by Arm Between Presentation and 3 Hours Post Administration of Study Drug	Placebo	No	17		Participants
Number of Participants With Successful Pain Interventions by Arm Between Presentation and 3 Hours Post Administration of Study Drug	Gabapentin	Yes	27		Participants
Number of Participants With Successful Pain Interventions by Arm Between Presentation and 3 Hours Post Administration of Study Drug	Placebo	Yes	25		Participants
Morphine Equivalent Doses Administered From Presentation to 3-hours Post Treatment With Gabapentin/Placebo	Gabapentin		0.12	Inter-Quartile Range 0.09 to 0.22	mg/kg
Morphine Equivalent Doses Administered From Presentation to 3-hours Post Treatment With Gabapentin/Placebo	Placebo		0.13	Inter-Quartile Range 0.09 to 0.22	mg/kg
Number of Participants With Successful Pain Interventions by Arm Between Presentation and Point of Decision for Either Hospital Admission or Discharge to Home	Gabapentin	No	10		Participants
Number of Participants With Successful Pain Interventions by Arm Between Presentation and Point of Decision for Either Hospital Admission or Discharge to Home	Placebo	No	17		Participants
Number of Participants With Successful Pain Interventions by Arm Between Presentation and Point of Decision for Either Hospital Admission or Discharge to Home	Gabapentin	Yes	30		Participants
Number of Participants With Successful Pain Interventions by Arm Between Presentation and Point of Decision for Either Hospital Admission or Discharge to Home	Placebo	Yes	27		Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Gabapentin	45
Overall Study	STARTED	Placebo	45
Overall Study	COMPLETED	Gabapentin	42
Overall Study	COMPLETED	Placebo	44
Overall Study	NOT COMPLETED	Gabapentin	3
Overall Study	NOT COMPLETED	Placebo	1

Source ClinicalTrials.gov

Adverse events14

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Dizziness	Nervous system disorders	Gabapentin	1	42	1
other	Dizziness	Nervous system disorders	Placebo	0	44	0
other	Fatigue	General disorders	Gabapentin	1	42	1
other	Fatigue	General disorders	Placebo	0	44	0
other	Headache	General disorders	Gabapentin	1	42	1
other	Headache	General disorders	Placebo	0	44	0
other	Pruritus	Skin and subcutaneous tissue disorders	Gabapentin	1	42	1
other	Pruritus	Skin and subcutaneous tissue disorders	Placebo	0	44	0
other	Pneumonitis	Respiratory, thoracic and mediastinal disorders	Gabapentin	1	42	1
other	Pneumonitis	Respiratory, thoracic and mediastinal disorders	Placebo	1	44	1

1 to 10 of 14Source ClinicalTrials.gov

See all 14 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Gabapentin	0	42
Total, all-cause mortality	Placebo	0	44
Total, other adverse events	Gabapentin	5	42
Total, other adverse events	Placebo	2	44
Total, serious adverse events	Gabapentin	0	42
Total, serious adverse events	Placebo	0	44

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Gabapentin vs Placebo: deaths from any cause	Trial comparisons
Gabapentin vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01954927

GET https://conductscience.org/api/trials/v1/NCT01954927/registered

API reference For AI assistants