IV Acetaminophen in Children Undergoing Palatoplasty
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ClinicalTrials.gov Identifier: NCT01760330 |
Recruitment Status :
Withdrawn
(Unable to obtain funding)
First Posted : January 4, 2013
Last Update Posted : March 8, 2016
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Condition or disease | Intervention/treatment | Phase |
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Cleft Palate | Drug: IV acetaminophen Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Double-Blinded, Randomized Comparison of Intravenous Acetaminophen Versus Placebo in Children Undergoing Palatoplasty |
Study Start Date : | December 2015 |
Estimated Primary Completion Date : | December 2016 |
Estimated Study Completion Date : | December 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: IV acetaminophen
IV acetaminophen administered q 4 hrs. for a total of 24 hrs.
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Drug: IV acetaminophen
Other Name: Ofirmev |
Placebo Comparator: Placebo
Normal saline administered IV every 4 hrs. for a total of 24 hrs.
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Drug: Placebo |
- Pain [ Time Frame: 24 hrs. post-op. ]Pain scores will be assessed.
- Opioid consumption [ Time Frame: 24 hrs. post-op ]

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- ASA physical status I or II
- Presenting for repair of palatoplasty with Drs. Kirschner or Pearson
Exclusion Criteria:
- ASA physical status > II
- Underlying Syndrome
- Significant co-morbid diseases (cardiac, pulmonary, neurological disease)
- Patients having concomitant procedures (tonsillectomy, adenoidectomy, etc.)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760330
United States, Ohio | |
Nationwide Children's Hospital | |
Columbus, Ohio, United States, 43205 |
Responsible Party: | Tarun Bhalla, MD, Clinical Assistant Professor, Nationwide Children's Hospital |
ClinicalTrials.gov Identifier: | NCT01760330 |
Other Study ID Numbers: |
IRB12-00709 |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | March 8, 2016 |
Last Verified: | March 2016 |
Cleft Palate Jaw Abnormalities Jaw Diseases Musculoskeletal Diseases Maxillofacial Abnormalities Craniofacial Abnormalities Musculoskeletal Abnormalities Stomatognathic Diseases Mouth Abnormalities Mouth Diseases |
Stomatognathic System Abnormalities Congenital Abnormalities Acetaminophen Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Antipyretics |