Evidence map›Paper›PMID 32649717›Full record

Trial reportPloS one2020

Intranasal fentanyl spray versus intravenous opioids for the treatment of severe pain in patients with cancer in the emergency department setting: A randomized controlled trial.

Srinivas R Banala, Osama K Khattab, Valda D Page, Carla L Warneke, Knox H Todd, Sai-Ching Jim Yeung

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02459964 (A Randomized Trial to Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain in Cancer Patients in the Emergency Department Setting), which is not on this map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 3 pooled it
2.9field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02459964 phase4completednot on this map

A Randomized Trial to Compare Fentanyl Nasal Spray With Intravenous Opioids to Treat Severe Pain in Cancer Patients in the Emergency Department Setting

TypeinterventionalSponsorM.D. Anderson Cancer CenterRan2015 to 2020Enrolled84ConditionsAdvanced Cancers, PainArmsFentanyl Nasal Spray, Hydromorphone Hydrochloride, Phone Call
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 3 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Hydromorphone for cancer pain.The Cochrane database of systematic reviews · 2021
    Pooled it
  4. Review
  5. Article
  6. Article
  7. Review
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 1 institution in 1 country.

Srinivas R BanalaDepartment of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.ORCID 0000-0003-3753-7867
Osama K KhattabDepartment of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Valda D PageDepartment of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Carla L WarnekeDepartment of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Knox H ToddDepartment of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.
Sai-Ching Jim YeungDepartment of Emergency Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, United States of America.ORCID 0000-0001-5170-0822
The University of Texas MD Anderson Cancer Center · US

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

objectiveIntranasal fentanyl (INF) quickly and noninvasively relieves severe pain, whereas intravenous hydromorphone (IVH) reliably treats severe cancer pain but requires vascular access. The trial evaluated the efficacy of INF relative to IVH for treating cancer patients with severe pain in an emergency department (ED) setting.

methodsWe randomized 82 patients from a comprehensive cancer center ED to receive INF (n = 42) or IVH (n = 40). Eligible patients reported severe pain at randomization (≥7, scale: 0 "none" to 10 "worst pain"). We conducted non-inferiority comparisons (non-inferiority margin = 0.9) of pain change from treatment initiation (T0) to one hour later (T60). T0 pain ratings were unavailable; therefore, we estimated T0 pain by comparing 1) T60 ratings, assuming similar group T0 ratings; 2) pain change, estimating T0 pain = randomization ratings, and 3) pain change, with T0 pain = 10 (IVH group) or T0 pain = randomization rating (INF group).

resultsAt T60, the upper 90% confidence limit (CL) of the mean log-transformed pain ratings for the INF group exceeded the mean IVH group rating by 0.16 points (>pain). Substituting randomization ratings for T0 pain, the lower 90% CL of mean pain change in the INF group extended 0.32 points below (<pain relief) mean change in the IVH group. Finally, assuming all subjects in the IVH group had maximum pain at T0 and that T0 pain for the INF group remained unchanged from randomization, the lower bound of the 90% CL for mean pain decrease in the INF group extended 1.37 points below (<pain relief) mean decrease in the IVH group. Time (minutes) from randomization until T0 was longer for the IVH (Median 23, IQR 12) versus INF (Median 15, IQR 11) group (P<0.001).

conclusionsTwo of three analyses supported non-inferiority of INF versus IVH, while one analysis was inconclusive. Compared to IVH, INF had the advantage of shorter time to administration.

trial registrationClinicalTrials.gov Identifier: NCT02459964.

Indexed as

Administration, IntranasalAdministration, IntravenousAdultAgedAnalgesics, OpioidCancer PainEmergency Service, HospitalFemaleFentanylHumansMaleMiddle AgedNeoplasmsAnalgesics, OpioidFentanyl

Identifiers

PMID32649717
PMCPMC7351205
OpenAlexW3041897702

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.